The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. Poor laboratory practice may yield compliance issues, higher costs, increased cycle time, and delayed product introductions. Avoiding all that means consistent lab review processes and good document controls. Here to review effective laboratory review processes, and their importance to regulatory compliance is David Strauss of SciCord.   About Our Guest: David Strauss, CEO and Founder, SciCord David co-founded SciCord LLC in 2014.  SciCord implemented the first production ELN solution in 2015 and has continued to grow both in functionality and customer base.  SciCord’s solution has evolved to encompass integrated ELN &amp; LIMS functionality with plug-and-play modules preconfigured to automate many laboratory functions.    Prior to 2014, David created an ELN application for GSK which virtually eliminated paper from the worldwide pre-clinical organization and was credited with a 30% productivity increase. David grew the application over 15 years to service more than 6000 scientists who in turn created over 800,000 experiments. As ELN champion, David was involved and often led the design, development, testing, validation, implementation, and regulatory compliance defense. David started his career with Merck, working in the lab and then specializing in information and laboratory automation.   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. Poor laboratory practice may yield compliance issues, higher costs, increased cycle time, and delayed product introductions. Avoiding all that means consistent lab review processes and good document controls. Here to review effective laboratory review processes, and their importance to regulatory compliance is David Strauss of SciCord. About Our Guest: David Strauss, CEO and Founder, SciCord David co-founded SciCord LLC in 2014.  SciCord implemented the first production ELN solution in 2015 and has continued to grow both in functionality and customer base.  SciCord’s solution has evolved to encompass integrated ELN &amp; LIMS functionality with plug-and-play modules preconfigured to automate many laboratory functions.    Prior to 2014, David created an ELN application for GSK which virtually eliminated paper from the worldwide pre-clinical organization and was credited with a 30% productivity increase. David grew the application over 15 years to service more than 6000 scientists who in turn created over 800,000 experiments. As ELN champion, David was involved and often led the design, development, testing, validation, implementation, and regulatory compliance defense. David started his career with Merck, working in the lab and then specializing in information and laboratory automation. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Laboratory Review Process and Its Impact on Compliance

The much-discussed revision to the EU GMP Annex 1 is expected to be published early this year, bringing some major changes to drug developers’ current process and manufacturing methods for sterile products. Although the draft revision has been widely shared and commented on, it is still unclear the total impact this document may have across regulated industries. Here to share their perspective on the Annex 1 Revision document is Patrick Nieuwenhuizen from PharmaLex.   About Our Guest: Patrick Nieuwenhuizen, Director, Senior Consultant with PharmaLex Ireland Patrick is an experienced Quality professional with a Microbiology &amp; Sterile Manufacturing background amassing expertise over the past 25 years in the Pharmaceutical Industry. Patrick has worked for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Vaccines, and Solid Oral Dose. He is also a qualified lead auditor and SME in Quality Control, Sterility Assurance, New Facility Design/Upgrade, and risk facilitator for Quality Risk Management.   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

The much-discussed revision to the EU GMP Annex 1 is expected to be published early this year, bringing some major changes to drug developers’ current process and manufacturing methods for sterile products. Although the draft revision has been widely shared and commented on, it is still unclear the total impact this document may have across regulated industries. Here to share their perspective on the Annex 1 Revision document is Patrick Nieuwenhuizen from PharmaLex. About Our Guest: Patrick Nieuwenhuizen, Director, Senior Consultant with PharmaLex Ireland Patrick is an experienced Quality professional with a Microbiology &amp; Sterile Manufacturing background amassing expertise over the past 25 years in the Pharmaceutical Industry. Patrick has worked for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Vaccines, and Solid Oral Dose. He is also a qualified lead auditor and SME in Quality Control, Sterility Assurance, New Facility Design/Upgrade, and risk facilitator for Quality Risk Management. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

EU GMP Annex 1 Revision 2022 Implementation

We have entered an era of accelerated digitalization in Life Sciences. Innovation has been thrust upon many across industries as a need to work remotely, automating tasks and virtual collaborations were necessary during the pandemic. Maintaining this accelerated pace, fully embracing the adoption of technology and automation, is the next hurdle we face. Will CSA get us there? Here to demystify the CSA shift is Ron Schardong, Sr. Director of Quality at J&amp;J.   About Our Guest: Ron Schardong is privileged to lead Johnson &amp; Johnson’s Technology Quality group responsible for Quality Management System for IT, Software as Medical Device, Externally Facing Digital Assets, external advocacy, quality strategies for emerging technologies, and digital surgery platforms across Medical Devices, Consumer and Pharmaceutical segments worldwide. He has over 25 years of experience in quality engineering, computer software validation, supplier quality, quality auditing, quality management, regulatory compliance, and regulatory affairs. Ron is one of the original members of the FICSA Group (FDA + Industry Computer Assurance Group).   Disclaimer: This presentation is intended for educational purposes only and does not replace independent professional judgment. Statements of fact and opinions expressed are those of the participant individually and, unless expressly stated to the contrary, are not the opinion or position of Johnson &amp; Johnson or its affiliates.   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

We have entered an era of accelerated digitalization in Life Sciences. Innovation has been thrust upon many across industries as a need to work remotely, automating tasks and virtual collaborations were necessary during the pandemic. Maintaining this accelerated pace, fully embracing the adoption of technology and automation, is the next hurdle we face. Will CSA get us there? Here to demystify the CSA shift is Ron Schardong, Sr. Director of Quality at J&amp;J. About Our Guest: Ron Schardong is privileged to lead Johnson &amp; Johnson’s Technology Quality group responsible for Quality Management System for IT, Software as Medical Device, Externally Facing Digital Assets, external advocacy, quality strategies for emerging technologies, and digital surgery platforms across Medical Devices, Consumer and Pharmaceutical segments worldwide. He has over 25 years of experience in quality engineering, computer software validation, supplier quality, quality auditing, quality management, regulatory compliance, and regulatory affairs. Ron is one of the original members of the FICSA Group (FDA + Industry Computer Assurance Group). Disclaimer: This presentation is intended for educational purposes only and does not replace independent professional judgment. Statements of fact and opinions expressed are those of the participant individually and, unless expressly stated to the contrary, are not the opinion or position of Johnson &amp; Johnson or its affiliates. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Critical Thinking, Assessing Risk, and Patient Safety – Setting the Record Straight on CSA

Welcome to Risk Revolution, a monthly series of Voices in Validation, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.    This week, series coordinator Nuala is joined once again by Risk Revolution co-hosts, Valerie Mulholland and Lori Richter with another old friend of the IVT network, Dr. James Vesper. Dr. Vesper will share his unique insights and deep learning on a very interesting aspect of RBDM, Risk Appetite, and the distinction between that and Risk Tolerance.    About Our Guest: Dr. Jim Vesper James Vesper, MPH, Ph.D. established and is president LearningPlus, Inc., and has had more than 30 years experience in the pharmaceutical industry, including 11 years at Eli Lilly and Company. Dr. Vesper worked eleven years at Eli Lilly and Company, Indianapolis. Since 1991, he and his firm, LearningPlus, have worked with pharma/biopharma, device, and blood products organizations around the world consulting on risk management, performance solutions, and custom GMP learning events. He has been a special advisor/consultant to the World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities working as a mentor and instructor for a number of different learning courses. Dr. Vesper has written five books, including Risk Assessment and Risk Management: Clear and Simple, and multiple technical articles. He has a BS in biology (Wheaton College), an MPH (University of Michigan School of Public Health), and a Ph.D. in Education from Murdoch University in Perth, Western Australia. Dr. Vesper may be contacted at jvesper@learningplus.com.   Resources From This Episode: What Are Risk Appetite &amp; Risk Tolerance In Pharma &amp; Medical Devices? Risk Revolution: The Best of Year One - an Anniversary Episode   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

Welcome to Risk Revolution, a monthly series of Voices in Validation, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.  This week, series coordinator Nuala is joined once again by Risk Revolution co-hosts, Valerie Mulholland and Lori Richter with another old friend of the IVT network, Dr. James Vesper. Dr. Vesper will share his unique insights and deep learning on a very interesting aspect of RBDM, Risk Appetite, and the distinction between that and Risk Tolerance.  About Our Guest: Dr. Jim Vesper James Vesper, MPH, Ph.D. established and is president LearningPlus, Inc., and has had more than 30 years experience in the pharmaceutical industry, including 11 years at Eli Lilly and Company. Dr. Vesper worked eleven years at Eli Lilly and Company, Indianapolis. Since 1991, he and his firm, LearningPlus, have worked with pharma/biopharma, device, and blood products organizations around the world consulting on risk management, performance solutions, and custom GMP learning events. He has been a special advisor/consultant to the World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities working as a mentor and instructor for a number of different learning courses. Dr. Vesper has written five books, including Risk Assessment and Risk Management: Clear and Simple, and multiple technical articles. He has a BS in biology (Wheaton College), an MPH (University of Michigan School of Public Health), and a Ph.D. in Education from Murdoch University in Perth, Western Australia. Dr. Vesper may be contacted at <a href="mailto:jvesper@learningplus.com">jvesper@learningplus.com</a>. Resources From This Episode: <a href="https://www.outsourcedpharma.com/doc/what-are-risk-appetite-risk-tolerance-in-pharma-medical-devices-0001" rel="nofollow" target="_blank">What Are Risk Appetite &amp; Risk Tolerance In Pharma &amp; Medical Devices?</a> <a href="https://www.ivtnetwork.com/article/risk-revolution-best-year-one-anniversary-episode" rel="nofollow" target="_blank">Risk Revolution: The Best of Year One - an Anniversary Episode</a> Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Risk Revolution: Risk Tolerance & Risk Acceptance

As we begin to harness the data delivered through AI, and further refine the processes around automation, supply chain, new norms around surface contamination and sanitization, IVT Network strives to bring to light some of the most innovative products and uses for the benefit of the entire life sciences industry. In drug and device production we are accustomed to concerns about contaminants, and mitigation of impurities, pollutants, and toxins. Heightened awareness around this topic is a direct result of the coronavirus pandemic, which has impacted the way we think and act on cleaning processes and will continue to do so for the long term.  Here today to talk about clean surface technologies and his invention BIOFoam is Scott Smith, CEO of AquaFlex. About Our Guest: Scott Smith, CEO and Founder, AquaFlex Scott is an inventor named on 11 issued patents and 14 patent-pending applications relating to Open-Cell foam technology (AquaFlex® and bioFOAM™) for testing/remediation of water, surfaces, and air contaminated with dangerous pathogens (e.g., MRSA, COVID-19, Legionella, C. diff), harmful algal blooms and related toxins, oil, and chemicals. Smith holds degrees from Baylor University (1987) and Harvard Business School (1991). For more information go to the following websites:  Truth About Germs, Go bioFOAM, and Go AquaFlex   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

As we begin to harness the data delivered through AI, and further refine the processes around automation, supply chain, new norms around surface contamination and sanitization, IVT Network strives to bring to light some of the most innovative products and uses for the benefit of the entire life sciences industry. In drug and device production we are accustomed to concerns about contaminants, and mitigation of impurities, pollutants, and toxins. Heightened awareness around this topic is a direct result of the coronavirus pandemic, which has impacted the way we think and act on cleaning processes and will continue to do so for the long term. Here today to talk about clean surface technologies and his invention BIOFoam is Scott Smith, CEO of AquaFlex. About Our Guest: Scott Smith, CEO and Founder, AquaFlex Scott is an inventor named on 11 issued patents and 14 patent-pending applications relating to Open-Cell foam technology (AquaFlex® and bioFOAM™) for testing/remediation of water, surfaces, and air contaminated with dangerous pathogens (e.g., MRSA, COVID-19, Legionella, C. diff), harmful algal blooms and related toxins, oil, and chemicals. Smith holds degrees from Baylor University (1987) and Harvard Business School (1991). For more information go to the following websites:  <a href="http://truthaboutgerms.com/" rel="nofollow" target="_blank">Truth About Germs</a><a href="https://gobiofoam.com/" rel="nofollow" target="_blank">, Go bioFOAM</a>, and <a href="https://aqflx.com/?fbclid=IwAR3pweutgha7QfvRiXf6pSL8xdWH6sqn9qk9Q_-F7UkVqJZSsm0m33j5gQ4" rel="nofollow" target="_blank">Go AquaFlex</a> Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Sustainability without Compromise, the story of BioFoam

Trending Technologies in Life Sciences - A Special episode series of Voices in Validation   This week, Stacey is joined by Dr. Peter Small, from Hyfe about an AI cough monitor that detects and records every cough and turns that into reliable clinical data.  We are working at accelerated speeds to digitalize and automate across pharmaceutical and medical devices. There are unique challenges inherent to emerging technologies in clinical trials development, scale-up, and manufacture. As we begin to harness the data delivered through AI, and further refine the processes around automation, IVT Network strives to bring to light some of the most innovative products and uses for the benefit of the entire life sciences industry. About Our Guest: Dr. Peter Small has had an eclectic career, with the common theme being the use of innovation to improve health care. He was chief medical resident at UCSF during the dawn of the HIV epidemic, did pioneering molecular epidemiologic research at Stanford University, and built and ran the TB program for the Bill and Melinda Gates Foundation. In 2015, he founded the Global Health Institute at Stony Brook University focused on the use of technology to deliver health care in remote Madagascar and Nepal. In 2019, he stepped in as the technical lead of a Gates-funded design-build firm which he recently left to focus on making cough count.   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

Trending Technologies in Life Sciences - A Special episode series of Voices in Validation This week, Stacey is joined by Dr. Peter Small, from Hyfe about an AI cough monitor that detects and records every cough and turns that into reliable clinical data.  We are working at accelerated speeds to digitalize and automate across pharmaceutical and medical devices. There are unique challenges inherent to emerging technologies in clinical trials development, scale-up, and manufacture. As we begin to harness the data delivered through AI, and further refine the processes around automation, IVT Network strives to bring to light some of the most innovative products and uses for the benefit of the entire life sciences industry. About Our Guest: Dr. Peter Small has had an eclectic career, with the common theme being the use of innovation to improve health care. He was chief medical resident at UCSF during the dawn of the HIV epidemic, did pioneering molecular epidemiologic research at Stanford University, and built and ran the TB program for the Bill and Melinda Gates Foundation. In 2015, he founded the Global Health Institute at Stony Brook University focused on the use of technology to deliver health care in remote Madagascar and Nepal. In 2019, he stepped in as the technical lead of a Gates-funded design-build firm which he recently left to focus on making cough count. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Measuring Cough As Clinical Evidence

This week, Stacey is joined by Justin Bechtel, of Bechtel Recruiting Group. This seems to be the era of the great resignation. Now more than ever in recent history employees have the advantage, and this is true across regulated industries as well. Unfortunately, the amount of training and experience necessary in maintaining GMP standards, delivering quality products, and patient-first service, means this can be an especially challenging environment to recruit, hire and retain. Justin is here to provide some guidance, both for hiring managers and employees, in navigating this volatile job environment.   About Our Guest: Justin Bechtel, Founder, and Lead Recruiter, Bechtel Recruiting Group  Justin began his career in the medical field where he specialized in pediatric and orthopedic physical therapy. Following the completion of clinical placements and doctoral degree, he moved into business development and recruiting, a career that allowed him to recognize his love of personal interaction and helping others more fully. Justin now works with hiring partners and job seekers, to provide an experience second to none, providing an individualized approach to hiring pain points for employers and hiring managers. He also assists job seekers, by simplifying the hiring job search process, coaching job seekers through the stressful process of job hunting. Justin attributes his success to a work ethic centered around quality, accountability, and honesty for both hiring partners and job seekers.   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

This week, Stacey is joined by Justin Bechtel, of Bechtel Recruiting Group. This seems to be the era of the great resignation. Now more than ever in recent history employees have the advantage, and this is true across regulated industries as well. Unfortunately, the amount of training and experience necessary in maintaining GMP standards, delivering quality products, and patient-first service, means this can be an especially challenging environment to recruit, hire and retain. Justin is here to provide some guidance, both for hiring managers and employees, in navigating this volatile job environment. About Our Guest: Justin Bechtel, Founder, and Lead Recruiter, Bechtel Recruiting Group  Justin began his career in the medical field where he specialized in pediatric and orthopedic physical therapy. Following the completion of clinical placements and doctoral degree, he moved into business development and recruiting, a career that allowed him to recognize his love of personal interaction and helping others more fully. Justin now works with hiring partners and job seekers, to provide an experience second to none, providing an individualized approach to hiring pain points for employers and hiring managers. He also assists job seekers, by simplifying the hiring job search process, coaching job seekers through the stressful process of job hunting. Justin attributes his success to a work ethic centered around quality, accountability, and honesty for both hiring partners and job seekers. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

The New Norm for Life Sciences Talent Evolution

Welcome to Risk Revolution, a monthly series of the Voices in Validation podcast, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.   In this episode, Stacey is joined by series coordinator Nuala Calnan and regular contributor Valerie Mulholland to discuss the ICH Q9 Revision with Kate Coleman of PharmaLex. The revisions were released for public consultation in November and are an improvement over the existing guidance but do leave a few areas that need to be explored further.   Resources from this episode: ICH Q9 Quality Risk Management Revision  Link to the new guidance Understanding the Concept of Formality In Quality Risk ... Risk Management, Knowledge Management and the Risk Knowledge Infinity Cycle on Risk Revolution Can ‘Fuzzy Logic’ Be Applied To Risk Management In Pharmaceuticals And Healthcare? Q9R1 presentation   About Our Guest: Kate Coleman Kate has worked in Quality roles in the Pharma Industry up to management level for 19 years, covering several platforms including Biologics, Sterile Fill Finish, Vaccines, and Oral Dose. Kate is a practicing QP, Principal Consultant, a qualified Lead Auditor and an SME in Risk Management, New Facility Design/Start Up, QC and Sterility Assurance.   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

Welcome to Risk Revolution, a monthly series of the Voices in Validation podcast, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk. In this episode, Stacey is joined by series coordinator Nuala Calnan and regular contributor Valerie Mulholland to discuss the ICH Q9 Revision with Kate Coleman of PharmaLex. The revisions were released for public consultation in November and are an improvement over the existing guidance but do leave a few areas that need to be explored further. Resources from this episode: <a href="https://www.ivtnetwork.com/article/ich-q9-quality-risk-management-revision" rel="nofollow" target="_blank">ICH Q9 Quality Risk Management Revision</a> <a href="https://database.ich.org/sites/default/files/ICH_Q9-R1_Document_Step2_Guideline_2021_1118.pdf" rel="nofollow" target="_blank">Link to the new guidance</a> <a href="https://www.ivtnetwork.com/article/understanding-concept-formality-quality-risk-management" rel="nofollow" target="_blank">Understanding the Concept of Formality In Quality Risk ...</a> <a href="https://www.ivtnetwork.com/article/risk-management-knowledge-management-and-risk-knowledge-infinity-cycle-risk-revolution" rel="nofollow" target="_blank">Risk Management, Knowledge Management and the Risk Knowledge Infinity Cycle on Risk Revolution</a> <a href="https://www.ivtnetwork.com/article/can-%E2%80%98fuzzy-logic%E2%80%99-be-applied-risk-management-pharmaceuticals-and-healthcare-risk-revolution" rel="nofollow" target="_blank">Can ‘Fuzzy Logic’ Be Applied To Risk Management In Pharmaceuticals And Healthcare?</a> <a href="https://database.ich.org/sites/default/files/ICH_Q9%28R1%29_Step_2_Presentation_2021_1126.pdf" rel="nofollow" target="_blank">Q9R1 presentation</a> About Our Guest: Kate Coleman Kate has worked in Quality roles in the Pharma Industry up to management level for 19 years, covering several platforms including Biologics, Sterile Fill Finish, Vaccines, and Oral Dose. Kate is a practicing QP, Principal Consultant, a qualified Lead Auditor and an SME in Risk Management, New Facility Design/Start Up, QC and Sterility Assurance. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Risk Revolution: ICH Q9 Revision, Is it enough?

This week, Stacey is joined by Brian Nunnally, Global Head of Quality Control, Seqirus. Stacey and Brian discuss updates and insights on laboratory operations since the pandemic began.  COVID has changed nearly every facet of society, and many of the changes will be permanent, not returning to the “old ways.” While we often take comfort in the status quo, this pandemic has allowed us many positives too, including better digital capabilities, and a better understanding of technological implications on drug development. New knowledge, new ways of working and collaborating, and improved methods of adaptability make this a perfect time to consider evolving our laboratories to meet new demands and maximize patient safety. About Our Guest: Brian K Nunnally, Ph.D., Global Head of Quality Control, Seqirus – A CSL Company Brian is the Head of Quality Control for Seqirus. Being the best quality control unit drives his passion. Prior to this role, he served as the Site Head of Quality for the Holly Springs Seqirus plant. Before joining Seqirus, he worked at Biogen as the Director of Global Stability and also as a Global Regulatory CMC lead. Before joining Biogen, he was in charge of Process Validation for the Pfizer, Sanford, NC site. He is a co-author, with John McConnell, of the book Six Sigma in the Pharmaceutical Industry [2007, Taylor &amp; Francis]. Dr. Nunnally has authored numerous publications in the field of analytical chemistry and operational excellence. He is a member of the CASSS Board of Directors. received two B.S. degrees (1994) from South Carolina Honors College, University of South Carolina, Columbia, and a Ph.D. degree (1998) in chemistry from Duke University, Durham, North Carolina. Prior to taking the Process Validation position, Dr. Nunnally worked in TO&amp;PS Regulatory Affairs. He was responsible for leading the Sanford site's contributions to one of the biggest filings in pharmaceutical history. Prior to joining TO&amp;PS Regulatory, Dr. Nunnally was the Associate Director for GMP Operations in Vaccine Analytical Development at Wyeth. The group he led was responsible for all Reference Standards, Stability, GMP Testing, and Validation for the vaccine candidates Wyeth was developing. Dr. Nunnally has previously worked for Eli Lilly and Company. While at Lilly, he was responsible for leading a Quality Control laboratory devoted to new method development, method optimization, analytical testing for process validation, and analytical testing for manufacturing investigations.   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

This week, Stacey is joined by Brian Nunnally, Global Head of Quality Control, Seqirus. Stacey and Brian discuss updates and insights on laboratory operations since the pandemic began. COVID has changed nearly every facet of society, and many of the changes will be permanent, not returning to the “old ways.” While we often take comfort in the status quo, this pandemic has allowed us many positives too, including better digital capabilities, and a better understanding of technological implications on drug development. New knowledge, new ways of working and collaborating, and improved methods of adaptability make this a perfect time to consider evolving our laboratories to meet new demands and maximize patient safety. About Our Guest: Brian K Nunnally, Ph.D., Global Head of Quality Control, Seqirus – A CSL Company Brian is the Head of Quality Control for Seqirus. Being the best quality control unit drives his passion. Prior to this role, he served as the Site Head of Quality for the Holly Springs Seqirus plant. Before joining Seqirus, he worked at Biogen as the Director of Global Stability and also as a Global Regulatory CMC lead. Before joining Biogen, he was in charge of Process Validation for the Pfizer, Sanford, NC site. He is a co-author, with John McConnell, of the book Six Sigma in the Pharmaceutical Industry [2007, Taylor &amp; Francis]. Dr. Nunnally has authored numerous publications in the field of analytical chemistry and operational excellence. He is a member of the CASSS Board of Directors. received two B.S. degrees (1994) from South Carolina Honors College, University of South Carolina, Columbia, and a Ph.D. degree (1998) in chemistry from Duke University, Durham, North Carolina. Prior to taking the Process Validation position, Dr. Nunnally worked in TO&amp;PS Regulatory Affairs. He was responsible for leading the Sanford site's contributions to one of the biggest filings in pharmaceutical history. Prior to joining TO&amp;PS Regulatory, Dr. Nunnally was the Associate Director for GMP Operations in Vaccine Analytical Development at Wyeth. The group he led was responsible for all Reference Standards, Stability, GMP Testing, and Validation for the vaccine candidates Wyeth was developing. Dr. Nunnally has previously worked for Eli Lilly and Company. While at Lilly, he was responsible for leading a Quality Control laboratory devoted to new method development, method optimization, analytical testing for process validation, and analytical testing for manufacturing investigations. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

The Quality Control Response to COVID Disruption in Labs

This week, Karen Ginsbury shares her ideas on data integrity lapses, and how automating now can save your business in the future. Karen looks at how the pharmaceutical industry and even society misunderstand what integration truly is. Karen shares her thoughts on how the industry can advance forward despite self-inflicted obstacles.  About Our Guest: Karen Ginsbury is a pharmaceutical consultant who brings hands-on experience in designing and implementing environmental control programs within multinational pharmaceutical companies. She started her career in the industry by taking EM samples on the factory floor and brings her own unique perspective to her lively and instructive presentations. Ms. Ginsbury has over twenty years of industry-based experience in quality assurance and compliance and has published a book on compliance auditing for pharmaceutical manufacturers. Ms. Ginsbury is a past holder of IVT’s Presentation of the Year and Web Seminar Presenter of the Year and regularly lectures around the world on pharmaceutical topics. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

This week, Karen Ginsbury shares her ideas on data integrity lapses, and how automating now can save your business in the future. Karen looks at how the pharmaceutical industry and even society misunderstand what integration truly is. Karen shares her thoughts on how the industry can advance forward despite self-inflicted obstacles.  About Our Guest: Karen Ginsbury is a pharmaceutical consultant who brings hands-on experience in designing and implementing environmental control programs within multinational pharmaceutical companies. She started her career in the industry by taking EM samples on the factory floor and brings her own unique perspective to her lively and instructive presentations. Ms. Ginsbury has over twenty years of industry-based experience in quality assurance and compliance and has published a book on compliance auditing for pharmaceutical manufacturers. Ms. Ginsbury is a past holder of IVT’s Presentation of the Year and Web Seminar Presenter of the Year and regularly lectures around the world on pharmaceutical topics. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Data Integrity and Integrating Automation

Our host, Stacey Bruzzese interviews industry experts from pharma, biotech, med devices and laboratories.

Voices In Validation

On today’s episode, Stacey Bruzzese welcomes Valarie King-Bailey back to talk about testing automation and how new technologies impact Computer Systems Validation (CSV). Stacey and Valarie cover a variety of topics: With Parma moving toward AI, IoT, Big Data and more, what are some of the trends specific to Computer Systems Validation? Over the next 12 months, what are some of the greatest obstacles to full integration of technologies for pharma companies? How do manufacturers choose between on-site servers, private cloud and public cloud options? What does the hosting choice mean for Cybersecurity professionals supporting the life science space? What will the impact be on traditional Computer Validation best practices? What does an integrated solution look like, and what steps must industry leaders take to move in the right direction? What parting thought does Valarie have for the listener?    Valarie King-Bailey, is CEO of OnShore Technology Group –a Chicago-based global IV&amp;V firm. Valarie has over 30 years of validation experience in the engineering and life sciences disciplines. She has conducted validation exercises for leading life sciences companies across the globe. She holds a B.S. in Civil &amp; Environmental Engineering from the University of Wisconsin -Madison and an MBA in Information Systems from Keller Graduate School of Management. She received a lifetime achievement award from the University of Wisconsin College of Engineering and is a UW College of Engineering Distinguished Alumni. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

On today’s episode, Stacey Bruzzese welcomes Valarie King-Bailey back to talk about testing automation and how new technologies impact Computer Systems Validation (CSV). Stacey and Valarie cover a variety of topics: <ul><li>With Parma moving toward AI, IoT, Big Data and more, what are some of the trends specific to Computer Systems Validation?</li> <li>Over the next 12 months, what are some of the greatest obstacles to full integration of technologies for pharma companies?</li> <li>How do manufacturers choose between on-site servers, private cloud and public cloud options?</li> <li>What does the hosting choice mean for Cybersecurity professionals supporting the life science space?</li> <li>What will the impact be on traditional Computer Validation best practices?</li> <li>What does an integrated solution look like, and what steps must industry leaders take to move in the right direction?</li> <li>What parting thought does Valarie have for the listener?</li> </ul> Valarie King-Bailey, is CEO of OnShore Technology Group –a Chicago-based global IV&amp;V firm. Valarie has over 30 years of validation experience in the engineering and life sciences disciplines. She has conducted validation exercises for leading life sciences companies across the globe. She holds a B.S. in Civil &amp; Environmental Engineering from the University of Wisconsin -Madison and an MBA in Information Systems from Keller Graduate School of Management. She received a lifetime achievement award from the University of Wisconsin College of Engineering and is a UW College of Engineering Distinguished Alumni. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Testing Automation – The Impact of Increasing Technology on CSV Processes

On today’s episode, Stacey Bruzzese welcomes Dr. Siegfried Schmitt, Vice President Regulatory and Access at PAREXEL.  They discuss how to avoid blind spots when it comes to data integrity. What systems and processes need to be included in my Data Integrity program? Who is responsible for oversight? Siegfried talks about a common misconception about electronic data Are informal notes and brainstorming sessions part of the data integrity equation? Why are so many of us not adhering to our own internal policies? How can I increase awareness to potential data integrity issues? Stacey and Siegfried discuss violations in conduct What is managements role in these cases? Siegfried shares some strategies for identifying hidden issues  Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity and Supply Chain, as well as a trusted expert for regulatory, compliance and industry-best-practices projects. Siegfried has more than 30 years’ experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. He received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com

On today’s episode, Stacey Bruzzese welcomes Dr. Siegfried Schmitt, Vice President Regulatory and Access at PAREXEL.  They discuss how to avoid blind spots when it comes to data integrity. <ul><li>What systems and processes need to be included in my Data Integrity program?</li> <li>Who is responsible for oversight?</li> <li>Siegfried talks about a common misconception about electronic data</li> <li>Are informal notes and brainstorming sessions part of the data integrity equation?</li> <li>Why are so many of us not adhering to our own internal policies?</li> <li>How can I increase awareness to potential data integrity issues?</li> <li>Stacey and Siegfried discuss violations in conduct</li> <li>What is managements role in these cases?</li> <li>Siegfried shares some strategies for identifying hidden issues</li> </ul> Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity and Supply Chain, as well as a trusted expert for regulatory, compliance and industry-best-practices projects. Siegfried has more than 30 years’ experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. He received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>

Data Integrity: Hidden issues and Blind Spots

On today’s episode, Stacey Bruzzese presents a recording with clips from a mock audit. The mock audit was recorded at a recent IVT conference and was facilitated by Alyce Deegan, Vice President of Data Integrity at Compliance Path LLC. What factors impede a zero-findings review? How can I prepare for an audit review? What can I expect from the inspectors? What kinds of questions do they ask? What is the best way to answer these questions?  These questions and more are covered during the mock audit. This episode has a lot of useful tips for anyone preparing for an audit. For additional information about Alyce’s presentation got to http://www.ivtnetwork.com/article/data-integrity-mock-inspection-mitigating-risk   Alyce Deegan has over 20 years of experience in Pharmaceutical, Medical Device and Gene Therapy industries.  Most recently, Alyce was the IT Director of Manufacturing and GxP Lab Systems at Juno Therapeutics a CAR-T Cell Therapy Manufacturing Plant located in Bothell, WA.  Throughout Alyce’s career she has held leadership positions in Quality, Validation and IT at companies such as Pfizer, Biogen and ThermoFisher.  Throughout her career she has built and continues to build "Unified Compliance Models" within companies to address the ever changing regulations and has been directly involved with multiple agency inspections throughout the years. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

On today’s episode, Stacey Bruzzese presents a recording with clips from a mock audit. The mock audit was recorded at a recent IVT conference and was facilitated by Alyce Deegan, Vice President of Data Integrity at Compliance Path LLC. <ul><li>What factors impede a zero-findings review?</li> <li>How can I prepare for an audit review?</li> <li>What can I expect from the inspectors?</li> <li>What kinds of questions do they ask?</li> <li>What is the best way to answer these questions?</li> </ul> These questions and more are covered during the mock audit. This episode has a lot of useful tips for anyone preparing for an audit. For additional information about Alyce’s presentation got to <a href="http://www.ivtnetwork.com/article/data-integrity-mock-inspection-mitigating-risk" rel="nofollow" target="_blank">http://www.ivtnetwork.com/article/data-integrity-mock-inspection-mitigating-risk</a> Alyce Deegan has over 20 years of experience in Pharmaceutical, Medical Device and Gene Therapy industries.  Most recently, Alyce was the IT Director of Manufacturing and GxP Lab Systems at Juno Therapeutics a CAR-T Cell Therapy Manufacturing Plant located in Bothell, WA.  Throughout Alyce’s career she has held leadership positions in Quality, Validation and IT at companies such as Pfizer, Biogen and ThermoFisher.  Throughout her career she has built and continues to build "Unified Compliance Models" within companies to address the ever changing regulations and has been directly involved with multiple agency inspections throughout the years. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

What Can I Expect During an Audit?

On this episode, Stacey Bruzzese welcomes back Dr. Siegfried Schmitt, Vice President Regulatory and Access at PAREXEL.  They discuss change management and the variety of factors that contribute to successful implementation.   What is included in a solid change management SOP? What are the best practices for identifying level of risk to products or systems? What is the best way to handle changes that are urgent, planned or temporary? What best practices exist for pre-approvals to changes in a like-for-like change scenario? Siegfried provides insights into streamlining the requirements of the change control process Siegfried shares some examples of GMP deficiencies and the specific findings What are the most important takeaways from the discussion?  Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity and Supply Chain, as well as a trusted expert for regulatory, compliance and industry-best-practices projects. Siegfried has more than 30 years’ experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. He received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

On this episode, Stacey Bruzzese welcomes back Dr. Siegfried Schmitt, Vice President Regulatory and Access at PAREXEL.  They discuss change management and the variety of factors that contribute to successful implementation. <ul><li>What is included in a solid change management SOP?</li> <li>What are the best practices for identifying level of risk to products or systems?</li> <li>What is the best way to handle changes that are urgent, planned or temporary?</li> <li>What best practices exist for pre-approvals to changes in a like-for-like change scenario?</li> <li>Siegfried provides insights into streamlining the requirements of the change control process</li> <li>Siegfried shares some examples of GMP deficiencies and the specific findings</li> <li>What are the most important takeaways from the discussion?</li> </ul> Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity and Supply Chain, as well as a trusted expert for regulatory, compliance and industry-best-practices projects. Siegfried has more than 30 years’ experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. He received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Change Management: Beyond the SOP

Stacey Bruzzese welcomes Alan Golden from Design Quality Consultants. Stacey and Alan have a conversation about a wide variety of change control topics. Alan gives a brief review of the product lifecycle When does change control start and end for a product? What should be included in change control SOP? Is the process of change control vastly different during development and post market? What are the key drivers for post-launch changes? What is unique about the review and documentation processes for post launch? What differs between pro-active versus reactive changes? What tools can be used for identifying the true effect of a change? What are the most common pitfalls to change control compliance?  Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&amp;D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations. Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years. Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Stacey Bruzzese welcomes Alan Golden from Design Quality Consultants. Stacey and Alan have a conversation about a wide variety of change control topics. <ul><li>Alan gives a brief review of the product lifecycle</li> <li>When does change control start and end for a product?</li> <li>What should be included in change control SOP?</li> <li>Is the process of change control vastly different during development and post market?</li> <li>What are the key drivers for post-launch changes?</li> <li>What is unique about the review and documentation processes for post launch?</li> <li>What differs between pro-active versus reactive changes?</li> <li>What tools can be used for identifying the true effect of a change?</li> <li>What are the most common pitfalls to change control compliance?</li> </ul> Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&amp;D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations. Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years. Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Change Control for Existing Products

On today’s episode, Stacey Bruzzese welcomes Ivan Soto, Director Manufacturing Validation for Emergent BioSolutions. They discuss a variety of aspects around the topic of data integrity.   Why are we hearing more about audits and audit reviews lately? Ivan talks about the history of audit trail reviews and the current challenges Why are audit trails important to safety, efficacy and reliability or pharmaceuticals and how does that impact data integrity efforts? Why is it important to assess the products’ entire legacy or history? Ivan shares advice on the frequency of periodic reviews and what should be included in those reviews He shares some tips for simplifying the review process Where does Ivan see the industry moving regarding audit trails?  Ivan has been in the life science industry for over 20 years and held several technical and management positions at different Pharmaceutical companies in the areas of Validation, IT Compliance, Quality Control and Quality Assurance. In his previous role under his leadership, his team successfully implemented a lean validation program. He is an active speaker at conferences related to validation cost reduction and efficiency improvements. He is also a contributing editor for the Journal of GxP Compliance and Validation Technology. He has a (B.S) in Chemistry from the Catholic University of Puerto Rico. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com

On today’s episode, Stacey Bruzzese welcomes Ivan Soto, Director Manufacturing Validation for Emergent BioSolutions. They discuss a variety of aspects around the topic of data integrity. <ul><li>Why are we hearing more about audits and audit reviews lately?</li> <li>Ivan talks about the history of audit trail reviews and the current challenges</li> <li>Why are audit trails important to safety, efficacy and reliability or pharmaceuticals and how does that impact data integrity efforts?</li> <li>Why is it important to assess the products’ entire legacy or history?</li> <li>Ivan shares advice on the frequency of periodic reviews and what should be included in those reviews</li> <li>He shares some tips for simplifying the review process</li> <li>Where does Ivan see the industry moving regarding audit trails?</li> </ul> Ivan has been in the life science industry for over 20 years and held several technical and management positions at different Pharmaceutical companies in the areas of Validation, IT Compliance, Quality Control and Quality Assurance. In his previous role under his leadership, his team successfully implemented a lean validation program. He is an active speaker at conferences related to validation cost reduction and efficiency improvements. He is also a contributing editor for the Journal of GxP Compliance and Validation Technology. He has a (B.S) in Chemistry from the Catholic University of Puerto Rico. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>

Audit Trails and Data Integrity in Pharmaceutical and Life Sciences

Stacey Bruzzese welcomes back Chris Wubbolt, Principal of QACV Consulting, to the show. Today, Stacey and Chris will be discussing how to manage data integrity expectations in GCP environment. Current guidelines that apply to Data Integrity What are the most important data integrity issues? The need for original documents for investigations What should SOP’s entail for firms to manage data risks? Specific regulations for eRecords and eSignatures Use of electronic documents for data integrity What have companies gone through during an audit of this type?    Investigations Operations Manual  2020 - https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM607759.pdf Guide to Inspections of Pharmaceutical Quality Control Laboratories - https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/pharmaceutical-quality-control-labs-793 Guidances and Manuals on Pharmaceutical Quality - https://www.fda.gov/drugs/pharmaceutical-quality-resources/guidances-and-manuals-pharmaceutical-quality MHRA Guidance - Good clinical practice for clinical trials - https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials MHRA Inspection Toolkit - http://www.ct-toolkit.ac.uk/routemap/mhra-inspection/ MHRA Inspectorate Computer System Validation – GCP - https://mhrainspectorate.blog.gov.uk/2017/04/20/computer-system-validation-gcp/ E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1    Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Stacey Bruzzese welcomes back Chris Wubbolt, Principal of QACV Consulting, to the show. Today, Stacey and Chris will be discussing how to manage data integrity expectations in GCP environment. <ul><li>Current guidelines that apply to Data Integrity</li> <li>What are the most important data integrity issues?</li> <li>The need for original documents for investigations</li> <li>What should SOP’s entail for firms to manage data risks?</li> <li>Specific regulations for eRecords and eSignatures</li> <li>Use of electronic documents for data integrity</li> <li>What have companies gone through during an audit of this type?</li> </ul> <ul><li>Investigations Operations Manual  2020 - <a href="https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM607759.pdf" rel="nofollow" target="_blank">https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM607759.pdf</a></li> <li>Guide to Inspections of Pharmaceutical Quality Control Laboratories - <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/pharmaceutical-quality-control-labs-793" rel="nofollow" target="_blank">https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/pharmaceutical-quality-control-labs-793</a></li> <li>Guidances and Manuals on Pharmaceutical Quality - <a href="https://www.fda.gov/drugs/pharmaceutical-quality-resources/guidances-and-manuals-pharmaceutical-quality" rel="nofollow" target="_blank">https://www.fda.gov/drugs/pharmaceutical-quality-resources/guidances-and-manuals-pharmaceutical-quality</a></li> <li>MHRA Guidance - Good clinical practice for clinical trials - <a href="https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials" rel="nofollow" target="_blank">https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials</a></li> <li>MHRA Inspection Toolkit - <a href="http://www.ct-toolkit.ac.uk/routemap/mhra-inspection/" rel="nofollow" target="_blank">http://www.ct-toolkit.ac.uk/routemap/mhra-inspection/</a></li> <li>MHRA Inspectorate Computer System Validation – GCP - <a href="https://mhrainspectorate.blog.gov.uk/2017/04/20/computer-system-validation-gcp/" rel="nofollow" target="_blank">https://mhrainspectorate.blog.gov.uk/2017/04/20/computer-system-validation-gcp/</a></li> <li>E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) - <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1" rel="nofollow" target="_blank">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1</a></li> </ul> Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Managing data integrity in GCP environment

Stacey Bruzzese welcomes Dr. Siegfried Schmitt back to the show. Today, Stacey and Siegfried discuss how the supply chains have been interrupted and what we can do to solve these issues. Supply Chain has been disrupted by covid-19 What exactly happens when supply chains have been changed? Is the drug supply being disrupted by covid-19? When could we see interruptions of drug supplies? Will our current efforts towards fighting covid-19 be enough to prevent breaks in the supply chain? Should we be concerned about the quality of medical products when non-medical companies are making medical equipment? Will this issue cause countries to re-evaluate medical imports? Will the supply chain model change forever? Where can companies find good references for how to evolve their current supply chain? Can companies streamline their process while maintain high quality?  Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity and Supply Chain, as well as a trusted expert for regulatory, compliance and industry-best-practices projects. Siegfried has more than 30 years’ experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. He received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry. Find Siegfried’s Book “Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers,” published in two volumes at DHI Books, the PDA Bookstore and Amazon.comDHI Books –Volume 1 - http://dhibooks.com/books/17353.html Volume 2 http://dhibooks.com/books/17354.html,PDA Bookstore –Volume 1 https://www.pda.org/bookstore/product-detail/5145-good-distribution-practice-volume-1 Volume 2 - https://www.pda.org/bookstore/product-detail/5148-good-distribution-practice-volume-2Amazon –Volume 1 - https://www.amazon.com/Good-Distribution-Practice-Healthcare-Manufacturers/dp/1942911386/ref=sr_1_2?dchild=1&amp;keywords=Good+Distribution+Practice%3A+A+Handbook+for+Healthcare+Manufacturers+and+Suppliers&amp;qid=1585932902&amp;sr=8-2 Volume 2 - https://www.amazon.com/Good-Distribution-Practice-Healthcare-Manufacturers/dp/1942911394/ref=sr_1_1?dchild=1&amp;keywords=Good+Distribution+Practice%3A+A+Handbook+for+Healthcare+Manufacturers+and+Suppliers&amp;qid=1585932902&amp;sr=8-1   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Stacey Bruzzese welcomes Dr. Siegfried Schmitt back to the show. Today, Stacey and Siegfried discuss how the supply chains have been interrupted and what we can do to solve these issues. <ul><li>Supply Chain has been disrupted by covid-19</li> <li>What exactly happens when supply chains have been changed?</li> <li>Is the drug supply being disrupted by covid-19?</li> <li>When could we see interruptions of drug supplies?</li> <li>Will our current efforts towards fighting covid-19 be enough to prevent breaks in the supply chain?</li> <li>Should we be concerned about the quality of medical products when non-medical companies are making medical equipment?</li> <li>Will this issue cause countries to re-evaluate medical imports?</li> <li>Will the supply chain model change forever?</li> <li>Where can companies find good references for how to evolve their current supply chain?</li> <li>Can companies streamline their process while maintain high quality?</li> </ul> Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity and Supply Chain, as well as a trusted expert for regulatory, compliance and industry-best-practices projects. Siegfried has more than 30 years’ experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. He received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry. Find Siegfried’s Book “Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers,” published in two volumes at DHI Books, the PDA Bookstore and <a href="http://Amazon.com" rel="nofollow" target="_blank">Amazon.com</a>DHI Books – Volume 1 - <a href="http://dhibooks.com/books/17353.html" rel="nofollow" target="_blank">http://dhibooks.com/books/17353.html</a> Volume 2 <a href="https://protect-us.mimecast.com/s/dryrCpYRz0uzyzJKBIDK3Eu?domain=dhibooks.com" rel="nofollow" target="_blank">http://dhibooks.com/books/17354.html</a>,PDA Bookstore – Volume 1 <a href="https://www.pda.org/bookstore/product-detail/5145-good-distribution-practice-volume-1" rel="nofollow" target="_blank">https://www.pda.org/bookstore/product-detail/5145-good-distribution-practice-volume-1</a> Volume 2 - <a href="https://www.pda.org/bookstore/product-detail/5148-good-distribution-practice-volume-2" rel="nofollow" target="_blank">https://www.pda.org/bookstore/product-detail/5148-good-distribution-practice-volume-2</a>Amazon – Volume 1 - <a href="https://www.amazon.com/Good-Distribution-Practice-Healthcare-Manufacturers/dp/1942911386/ref=sr_1_2?dchild=1&amp;keywords=Good+Distribution+Practice%3A+A+Handbook+for+Healthcare+Manufacturers+and+Suppliers&amp;qid=1585932902&amp;sr=8-2" rel="nofollow" target="_blank">https://www.amazon.com/Good-Distribution-Practice-Healthcare-Manufacturers/dp/1942911386/ref=sr_1_2?dchild=1&amp;keywords=Good+Distribution+Practice%3A+A+Handbook+for+Healthcare+Manufacturers+and+Suppliers&amp;qid=1585932902&amp;sr=8-2</a> Volume 2 - <a href="https://www.amazon.com/Good-Distribution-Practice-Healthcare-Manufacturers/dp/1942911394/ref=sr_1_1?dchild=1&amp;keywords=Good+Distribution+Practice%3A+A+Handbook+for+Healthcare+Manufacturers+and+Suppliers&amp;qid=1585932902&amp;sr=8-1" rel="nofollow" target="_blank">https://www.amazon.com/Good-Distribution-Practice-Healthcare-Manufacturers/dp/1942911394/ref=sr_1_1?dchild=1&amp;keywords=Good+Distribution+Practice%3A+A+Handbook+for+Healthcare+Manufacturers+and+Suppliers&amp;qid=1585932902&amp;sr=8-1</a> Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Supply Chain Management in Times of Uncertainty

Stacey Bruzzese welcomes former FDA investigator Alan Schwartz to talk about how medical device companies are handling the covid-19 pandemic. This is the FDA enforcement policy that is discussed throughout the show. https://www.fda.gov/media/136449/download Topics Include: How can we converse masks and respirators while demand is high? Will the influx of new masks and respirators be up to FDA standards? What is the FDA doing to halt counterfeit respirators? Will the quality of medical devices go down during this time? Is the US too late to effectively handle the demand? What are companies doing to conserve their products right now? How does this pandemic effect reliability testing? What will be the long term impact on medical device companies?  Alan Schwartz began his career as an FDA investigator in 1972. He rose to the position of supervisor of field operation prior to leaving the FDA in 1978 to start his consulting career. Alan has implemented over 100s of quality systems and led numerous companies worldwide successfully through FDA audits and ISO certification. Alan has trained over 15,000 individuals in the FDA regulations and the QSR/cGMP. Mr. Schwartz has over 50 articles published on Quality Assurance and Regulatory Affairs and was a member of the industry group that defined HACCP regulations. He has been Executive Vice President of mdi since 1994. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Stacey Bruzzese welcomes former FDA investigator Alan Schwartz to talk about how medical device companies are handling the covid-19 pandemic. This is the FDA enforcement policy that is discussed throughout the show. <a href="https://www.fda.gov/media/136449/download" rel="nofollow" target="_blank">https://www.fda.gov/media/136449/download</a> Topics Include: <ul><li>How can we converse masks and respirators while demand is high?</li> <li>Will the influx of new masks and respirators be up to FDA standards?</li> <li>What is the FDA doing to halt counterfeit respirators?</li> <li>Will the quality of medical devices go down during this time?</li> <li>Is the US too late to effectively handle the demand?</li> <li>What are companies doing to conserve their products right now?</li> <li>How does this pandemic effect reliability testing?</li> <li>What will be the long term impact on medical device companies?</li> </ul> Alan Schwartz began his career as an FDA investigator in 1972. He rose to the position of supervisor of field operation prior to leaving the FDA in 1978 to start his consulting career. Alan has implemented over 100s of quality systems and led numerous companies worldwide successfully through FDA audits and ISO certification. Alan has trained over 15,000 individuals in the FDA regulations and the QSR/cGMP. Mr. Schwartz has over 50 articles published on Quality Assurance and Regulatory Affairs and was a member of the industry group that defined HACCP regulations. He has been Executive Vice President of mdi since 1994. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

COVID-19 and the Increased Demand for Personal Protective Equipment

Stacey Bruzzese welcomes Igor Gorsky to the show. Today, Stacey and Igor will be covering the essentials of regulatory guidelines and what goes into writing them. Why are the guidelines so important? What is the process for developing new guidelines? What is superior about the lifecycle approach? Why isn’t complying with Health Authority regulations enough to assure top quality? What would the industry do without Validation? What is a good business model to follow in this space?  Igor is the principal consultant at Valsouce Inc. He also is a Pharmaceutical and Biotechnology Industries’ Leader with broad strategic and tactical leadership experience spanning Development, Commercial Manufacturing, and Quality organizations. Proven record in implementing Validation Master Plans based on Risk Management and principles outlined in ICH Guidances Q8, Q9, Q10 and Q11 in variety of pharmaceutical facilities. Expertise in implementing Quality by Design in manufacturing environment throughout commercial product launch. Proven track record in building Validation organizations, establishing and implementing validation policies and training programs. Direct personal interface with FDA, MHRA, ANVISA and other regulatory organizations. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Stacey Bruzzese welcomes Igor Gorsky to the show. Today, Stacey and Igor will be covering the essentials of regulatory guidelines and what goes into writing them. <ul><li>Why are the guidelines so important?</li> <li>What is the process for developing new guidelines?</li> <li>What is superior about the lifecycle approach?</li> <li>Why isn’t complying with Health Authority regulations enough to assure top quality?</li> <li>What would the industry do without Validation?</li> <li>What is a good business model to follow in this space?</li> </ul> Igor is the principal consultant at Valsouce Inc. He also is a Pharmaceutical and Biotechnology Industries’ Leader with broad strategic and tactical leadership experience spanning Development, Commercial Manufacturing, and Quality organizations. Proven record in implementing Validation Master Plans based on Risk Management and principles outlined in ICH Guidances Q8, Q9, Q10 and Q11 in variety of pharmaceutical facilities. Expertise in implementing Quality by Design in manufacturing environment throughout commercial product launch. Proven track record in building Validation organizations, establishing and implementing validation policies and training programs. Direct personal interface with FDA, MHRA, ANVISA and other regulatory organizations. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Understanding Regulatory Guidelines with Igor Gorsky

Stacey Bruzzese welcomes Dr. Tim Sandle, he is the head of microbiology and sterility assurance at Bio Products Laboratory Limited. Stacey and Tim have a conversation about the European GMP annex 1 and what the final draft reveals. What annex 1 actually is? What are the biggest changes from the previous version to the current document? What are some of the broad reaching impacts that annex 1 will have? What was lacking in previous versions, regarding contamination control? The distinction of viable counts and non-viable particle counts in this draft cause for concern. How will pharmaceutical companies produce the correct data based on the new verbiage in this document? How could this document affect the current processes in the lab? How will environment monitoring be changed moving forward? Will there be too many new steps for labs to monitor their clean rooms? Will we see more relaxed views on post sterilization integrity testing? Does Tim see this latest revision as an improved to the most recent draft?    Dr. Sandle is the Head of Microbiology and Sterility Assurance at Bio Products Laboratory Limited (a pharmaceutical organization). Dr. Sandle is a chartered biologist (Royal Society for Biology) and holds a first class honors degree in Applied Biology; a Masters degree in education; and obtained his doctorate from Keele University. Dr. Sandle has over twenty-five years experience of designing and operating a range of microbiological tests (including sterility testing, endotoxin LAL methodlogy, microbial enumeration, environmental monitoring, particle counting, bioburden, isolators and water testing). In addition, Dr. Sandle is experienced in microbiological and quality batch review, microbiological investigation and policy development. Dr. Sandle is the editor of the Pharmaceutical Microbiology Interest Group Journal and runs an on-line microbiology website and forum (http://www.pharmamicroresources.com/). Dr. Sandle is an experienced auditor and frequently acts as a consultant to the pharmaceutical and healthcare sectors. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Stacey Bruzzese welcomes Dr. Tim Sandle, he is the head of microbiology and sterility assurance at Bio Products Laboratory Limited. Stacey and Tim have a conversation about the European GMP annex 1 and what the final draft reveals. <ul><li>What annex 1 actually is?</li> <li>What are the biggest changes from the previous version to the current document?</li> <li>What are some of the broad reaching impacts that annex 1 will have?</li> <li>What was lacking in previous versions, regarding contamination control?</li> <li>The distinction of viable counts and non-viable particle counts in this draft cause for concern.</li> <li>How will pharmaceutical companies produce the correct data based on the new verbiage in this document?</li> <li>How could this document affect the current processes in the lab?</li> <li>How will environment monitoring be changed moving forward?</li> <li>Will there be too many new steps for labs to monitor their clean rooms?</li> <li>Will we see more relaxed views on post sterilization integrity testing?</li> <li>Does Tim see this latest revision as an improved to the most recent draft?</li> </ul> Dr. Sandle is the Head of Microbiology and Sterility Assurance at Bio Products Laboratory Limited (a pharmaceutical organization). Dr. Sandle is a chartered biologist (Royal Society for Biology) and holds a first class honors degree in Applied Biology; a Masters degree in education; and obtained his doctorate from Keele University. Dr. Sandle has over twenty-five years experience of designing and operating a range of microbiological tests (including sterility testing, endotoxin LAL methodlogy, microbial enumeration, environmental monitoring, particle counting, bioburden, isolators and water testing). In addition, Dr. Sandle is experienced in microbiological and quality batch review, microbiological investigation and policy development. Dr. Sandle is the editor of the Pharmaceutical Microbiology Interest Group Journal and runs an on-line microbiology website and forum (<a href="http://www.pharmamicroresources.com/" rel="nofollow" target="_blank">http://www.pharmamicroresources.com/</a>). Dr. Sandle is an experienced auditor and frequently acts as a consultant to the pharmaceutical and healthcare sectors. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Annex 1 - What the final draft reveals, and the impact to pharma.

On today’s episode, Stacey Bruzzese welcomes Chris Wubbolt to talk about staying compliant with compliant product compliant handling systems. Stacey and Chris talk about a variety of topics: Overview of the type of systems and the current requirements impacting them How does this integrate into an existing QRM system and does it need to be managed by a separate implementation and monitoring team? What exactly constitutes a “product complaint” under regulatory standards? What are the most common errors or omissions? Outdated systems, Lack of information, and Poorly defined procedures. How can an organization overcome these challenges? What are all of the QMS components? What are three steps they can take to ensure compatibility with existing QRM? What are the best practices for companies to start their QRM? How often should internal audits be done of the product complaint process?  Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

On today’s episode, Stacey Bruzzese welcomes Chris Wubbolt to talk about staying compliant with compliant product compliant handling systems. Stacey and Chris talk about a variety of topics: <ul><li>Overview of the type of systems and the current requirements impacting them</li> <li>How does this integrate into an existing QRM system and does it need to be managed by a separate implementation and monitoring team?</li> <li>What exactly constitutes a “product complaint” under regulatory standards?</li> <li>What are the most common errors or omissions?</li> <li>Outdated systems, Lack of information, and Poorly defined procedures. How can an organization overcome these challenges?</li> <li>What are all of the QMS components?</li> <li>What are three steps they can take to ensure compatibility with existing QRM?</li> <li>What are the best practices for companies to start their QRM?</li> <li>How often should internal audits be done of the product complaint process?</li> </ul> Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Staying Compliant with Compliant Product Complaint Handling Systems w/Chris Wubbolt

Voices in Validation   Why is it important to contribute to industry publications?   On this episode, Stacey Bruzzese is joined by Paul Pluta, Editor-In-Chief of the Journals of Validation Technologies and GXP Compliance. Stacey and Paul talk about the need for more contributors to industry publications, not only for industry growth but personal growth as well.   Why role did IVT originally serve? How to network between industry personnel and consultants? The differences between JVT and GXP What are some of the most impactful topics covered in JVT and GXP? How does IVT stay relevant in an ever changing landscape? Why does contributing to IVT help personal growth?    IVT has been around for more than 20-years. As its name suggests the purpose of IVT has always been to provide learning, networking and industry growth opportunities for professionals in the validation and compliance space. Over the years many things within the industry have changed, but IVT continues to work to  expand the knowledge base for those working in FDA Regulated industries. Today  we are going to chat with Paul Pluta, Editor-In-Chief of the Journals of Validation Technologies and GXP Compliance. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Voices in Validation Why is it important to contribute to industry publications? On this episode, Stacey Bruzzese is joined by Paul Pluta, Editor-In-Chief of the Journals of Validation Technologies and GXP Compliance. Stacey and Paul talk about the need for more contributors to industry publications, not only for industry growth but personal growth as well. <ul><li>Why role did IVT originally serve?</li> <li>How to network between industry personnel and consultants?</li> <li>The differences between JVT and GXP</li> <li>What are some of the most impactful topics covered in JVT and GXP?</li> <li>How does IVT stay relevant in an ever changing landscape?</li> <li>Why does contributing to IVT help personal growth?</li> </ul> IVT has been around for more than 20-years. As its name suggests the purpose of IVT has always been to provide learning, networking and industry growth opportunities for professionals in the validation and compliance space. Over the years many things within the industry have changed, but IVT continues to work to  expand the knowledge base for those working in FDA Regulated industries. Today  we are going to chat with Paul Pluta, Editor-In-Chief of the Journals of Validation Technologies and GXP Compliance. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

What is the benefit of contributing to industry publications? with Paul Pluta

Stacey Bruzzese welcomes Roberta Goode back to the show. Today, Stacey and Roberta will be covering the essentials of designing for manufacturability.   Roberta details the 8 essentials of DFM Why is Designing for Manufacturability important for medical device manufacturers? Does standardization of materials help shorten the product development cycle? What’s the next step after determining the practical part count? What is Poka-Yoke? What other points should be considered when scaling up manufacturing?    DFMA References Assembly Automation and Product Design G. Boothroyd, Marcell Dekker, Inc. 1992 Product Design for Manufacture and Assembly G. Boothroyd and P. Dewhurst, G. Boothroyd Dewhurst, Inc. 1989 Marcell Dekker, Inc.  1994 Design and Analysis of Manufacturing Systems Prof. Rajan Suri University of Wisconsin  1995 Product Design for Assembly: The Methodology Applied G. Lewis and H. Connelly Simultaneous Engineering Study of Phase II Injector Assembly Line Giddings &amp; Lewis  1997 Design for Manufacturing Society of Manufacturing Engineers, (VIDEO) Introduction to Design for (Cost Effective) Assembly and Manufacturing David Steinstra, Rose-Hulman, 2015 IVT’s Medical Device Handbook: http://www.ivtnetwork.com/article/medical-device-validation-handbook Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers.  After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge.  In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.    Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Stacey Bruzzese welcomes Roberta Goode back to the show. Today, Stacey and Roberta will be covering the essentials of designing for manufacturability. <ul><li>Roberta details the 8 essentials of DFM</li> <li>Why is Designing for Manufacturability important for medical device manufacturers?</li> <li>Does standardization of materials help shorten the product development cycle?</li> <li>What’s the next step after determining the practical part count?</li> <li>What is Poka-Yoke?</li> <li>What other points should be considered when scaling up manufacturing?</li> </ul> DFMA References Assembly Automation and Product Design G. Boothroyd, Marcell Dekker, Inc. 1992 Product Design for Manufacture and Assembly G. Boothroyd and P. Dewhurst, G. Boothroyd Dewhurst, Inc. 1989 Marcell Dekker, Inc.  1994 Design and Analysis of Manufacturing Systems Prof. Rajan Suri University of Wisconsin  1995 Product Design for Assembly: The Methodology Applied G. Lewis and H. Connelly Simultaneous Engineering Study of Phase II Injector Assembly Line Giddings &amp; Lewis  1997 Design for Manufacturing Society of Manufacturing Engineers, (VIDEO) Introduction to Design for (Cost Effective) Assembly and Manufacturing David Steinstra, Rose-Hulman, 2015 IVT’s Medical Device Handbook: <a href="http://www.ivtnetwork.com/article/medical-device-validation-handbook" rel="nofollow" target="_blank">http://www.ivtnetwork.com/article/medical-device-validation-handbook</a> Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers.  After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge.  In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.    Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

8 Essentials of Designing for Manufacturability

On this episode, Stacey Bruzzese is joined by Karen Ginsbury, President &amp; CEO of PCI Pharmaceutical Consulting Israel. Stacey and Karen talk about what’s new with global systems and regulatory guidelines.  What’s new in Quality Management System For Virtual companies, what are their responsibilities in terms of quality systems? What’s the new EU guidance around vendors and responsibility? What will the impact be of new Draft PIC/S recommendations on how to demonstrate the effectiveness of a Pharmaceutical Quality System? What are the differences in protocols for QRM systems in digitally enabled and fully automated labs? What’s happening with Annex 1?  More information on the topics discussed can be found at: ISO 18091:2019 Quality management systems — Guidelines for the application of ISO 9001 in local government https://www.iso.org/standard/72808.html Validation Week 2020 http://www.cbinet.com/conference/pi20083 FDA Information on PQS https://www.fda.gov/media/92818/download ICH Q10 Quality Management https://www.fda.gov/media/71553/download IT and Computerized Systems Conference http://www.cbinet.com/conference/pi20045 ICH guideline Q10 on pharmaceutical quality system  http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002871.pdf ICH guideline Q9 on quality risk management http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002873.pdf Karen has over twenty years of experience in the pharmaceutical industry. ... After leaving Teva, Karen set up her own consultancy company, PCI Pharmaceutical Consulting Israel Ltd which has been providing services to the pharmaceutical industry worldwide for the past 14 years.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

On this episode, Stacey Bruzzese is joined by Karen Ginsbury, President &amp; CEO of PCI Pharmaceutical Consulting Israel. Stacey and Karen talk about what’s new with global systems and regulatory guidelines.  What’s new in Quality Management System <ul><li>For Virtual companies, what are their responsibilities in terms of quality systems?</li> <li>What’s the new EU guidance around vendors and responsibility?</li> <li>What will the impact be of new Draft PIC/S recommendations on how to demonstrate the effectiveness of a Pharmaceutical Quality System?</li> <li>What are the differences in protocols for QRM systems in digitally enabled and fully automated labs?</li> <li>What’s happening with Annex 1?</li> </ul> More information on the topics discussed can be found at: ISO 18091:2019 Quality management systems — Guidelines for the application of ISO 9001 in local government <a href="https://www.iso.org/standard/72808.html" rel="nofollow" target="_blank">https://www.iso.org/standard/72808.html</a> Validation Week 2020 <a href="http://www.cbinet.com/conference/pi20083" rel="nofollow" target="_blank">http://www.cbinet.com/conference/pi20083</a> FDA Information on PQS <a href="https://www.fda.gov/media/92818/download" rel="nofollow" target="_blank">https://www.fda.gov/media/92818/download</a> ICH Q10 Quality Management <a href="https://www.fda.gov/media/71553/download" rel="nofollow" target="_blank">https://www.fda.gov/media/71553/download</a> IT and Computerized Systems Conference <a href="http://www.cbinet.com/conference/pi20045" rel="nofollow" target="_blank">http://www.cbinet.com/conference/pi20045</a> ICH guideline Q10 on pharmaceutical quality system <a href="http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002871.pdf" rel="nofollow" target="_blank">http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002871.pdf</a> ICH guideline Q9 on quality risk management <a href="http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002873.pdf" rel="nofollow" target="_blank">http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002873.pdf</a> Karen has over twenty years of experience in the pharmaceutical industry. ... After leaving Teva, Karen set up her own consultancy company, PCI Pharmaceutical Consulting Israel Ltd which has been providing services to the pharmaceutical industry worldwide for the past 14 years.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

What’s Trending and Timely in Life Sciences?

On today’s episode, Stacey Bruzzese welcomes Chris Wubbolt to talk about validation of manufacturing equipment, processes and computer systems – both hardware and software. Stacey and Chris talk about a variety of topics: Chris gives a brief overview of CSV and why it’s important to the integrity of the product Chris explains why, in an FDA regulated laboratory, CSV is not only concerned with computer hardware and software What is the impact on the Pharma industry of going paperless and relying more on computer documentation? What are some of the biggest hurdles for compliance? What are some of the best practices for big data and data integrity? How will implementing more technologies like IoT and AI impact CSV? Where does Chris see things heading in the future?  Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

On today’s episode, Stacey Bruzzese welcomes Chris Wubbolt to talk about validation of manufacturing equipment, processes and computer systems – both hardware and software. Stacey and Chris talk about a variety of topics: <ul><li>Chris gives a brief overview of CSV and why it’s important to the integrity of the product</li> <li>Chris explains why, in an FDA regulated laboratory, CSV is not only concerned with computer hardware and software</li> <li>What is the impact on the Pharma industry of going paperless and relying more on computer documentation?</li> <li>What are some of the biggest hurdles for compliance?</li> <li>What are some of the best practices for big data and data integrity?</li> <li>How will implementing more technologies like IoT and AI impact CSV?</li> <li>Where does Chris see things heading in the future?</li> </ul> Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

The intricacies of Computer System Validation in the Pharmaceutical industry

On today’s episode, Stacey Bruzzese welcomes Roberta Good, the founder of Goode Compliance for the second part of our 3-part series.  Stacey and Roberta dive into the design and development of medical devices. Stacey and Roberta cover a variety of topics: What are the tasks that make up the design and development phase? Do people develop prototypes and when is the right time to do that? How is human factors design applied to engineering medical device? What records and documents need to be considered during the design and development? How do Design for Manufacturing and Six Sigma get incorporated? Roberta highlights the typical challenges when planning for packaging, labeling and product delivery What’s the difference between validation and verification? How does managing compliance through the risk management cycle help ensure quality and safety are built into the product? How do labeling requirements affect the expiration date?  The following links have useful companion information for this episode: FDA Labeling (General) https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling UDI System: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system Investigational Device Exceptions: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812 Test method validation article on IVT Network: http://www.ivtnetwork.com/article/test-method-validation-medical-devices http://www.ivtnetwork.com/article/method-validation-medical-devices-regulatory-guidance Method Validation Guidelines: https://www.fda.gov/science-research/field-science-and-laboratories/method-validation-guidelines Design Controls: https://ubm.box.com/s/gwkqg1wweccrjs683bjp28x8zsu7qnhc   Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers.  After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge.  In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.    Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

On today’s episode, Stacey Bruzzese welcomes Roberta Good, the founder of Goode Compliance for the second part of our 3-part series.  Stacey and Roberta dive into the design and development of medical devices. Stacey and Roberta cover a variety of topics: <ul><li>What are the tasks that make up the design and development phase?</li> <li>Do people develop prototypes and when is the right time to do that?</li> <li>How is human factors design applied to engineering medical device?</li> <li>What records and documents need to be considered during the design and development?</li> <li>How do Design for Manufacturing and Six Sigma get incorporated?</li> <li>Roberta highlights the typical challenges when planning for packaging, labeling and product delivery</li> <li>What’s the difference between validation and verification?</li> <li>How does managing compliance through the risk management cycle help ensure quality and safety are built into the product?</li> <li>How do labeling requirements affect the expiration date?</li> </ul> The following links have useful companion information for this episode: FDA Labeling (General) <a href="https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling" rel="nofollow" target="_blank">https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling</a> UDI System: <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system" rel="nofollow" target="_blank">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system</a> Investigational Device Exceptions: <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812" rel="nofollow" target="_blank">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812</a> Test method validation article on IVT Network: <a href="http://www.ivtnetwork.com/article/test-method-validation-medical-devices" rel="nofollow" target="_blank">http://www.ivtnetwork.com/article/test-method-validation-medical-devices</a> <a href="http://www.ivtnetwork.com/article/method-validation-medical-devices-regulatory-guidance" rel="nofollow" target="_blank">http://www.ivtnetwork.com/article/method-validation-medical-devices-regulatory-guidance</a> Method Validation Guidelines: <a href="https://www.fda.gov/science-research/field-science-and-laboratories/method-validation-guidelines" rel="nofollow" target="_blank">https://www.fda.gov/science-research/field-science-and-laboratories/method-validation-guidelines</a> Design Controls: <a href="https://ubm.box.com/s/gwkqg1wweccrjs683bjp28x8zsu7qnhc" rel="nofollow" target="_blank">https://ubm.box.com/s/gwkqg1wweccrjs683bjp28x8zsu7qnhc</a> Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers.  After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge.  In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.    Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Part 2 of Get Your Medical Device to Market in 10 Easy Steps: Design and Development

On today’s episode, Stacey Bruzzese welcomes Roberta Goode, the founder of Goode Compliance. Stacey and Roberta talk about the planning stage to get your medical device to market. Stacey and Roberta cover a variety of topics: Roberta start by outlining the steps covered in this first episode How do we ensure we’re building a product the meets a clinical need? What goes into a product launch plan? What are the considerations if you plan to introduce the product outside of the United Sates? Why do investors need to be aware of how regulatory bodies classify your product? How does the business plan for a medical device differ from other products? What should be included in an initial risk management plan? What are the key elements to streamline the funding process? Should I try to fund the full project or just the first few phases/milestones?  The following links have useful companion information for this episode: EU Medical Device Standards: http://eumdr.com/ Risk management Standards: ISO 14971 - https://www.emergobyul.com/services/worldwide/iso-14971-consulting EU Directory: https://ubm.box.com/s/2nqk6h7m0r69gb8bp4a3gvx7j16zlm9p FDA: CDRH Guidance: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidance-development Searchable product classification: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm FDA Good Guidance Practices: https://ubm.box.com/s/ejdhq3ta2n8j0jzaod0bb3qjm3bre6pc Funding Resources FDA 510(k) Premarket Submission https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers.  After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge.  In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.    Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

On today’s episode, Stacey Bruzzese welcomes Roberta Goode, the founder of Goode Compliance. Stacey and Roberta talk about the planning stage to get your medical device to market. Stacey and Roberta cover a variety of topics: <ul><li>Roberta start by outlining the steps covered in this first episode</li> <li>How do we ensure we’re building a product the meets a clinical need?</li> <li>What goes into a product launch plan?</li> <li>What are the considerations if you plan to introduce the product outside of the United Sates?</li> <li>Why do investors need to be aware of how regulatory bodies classify your product?</li> <li>How does the business plan for a medical device differ from other products?</li> <li>What should be included in an initial risk management plan?</li> <li>What are the key elements to streamline the funding process?</li> <li>Should I try to fund the full project or just the first few phases/milestones?</li> </ul> The following links have useful companion information for this episode: EU Medical Device Standards: <a href="http://eumdr.com/" rel="nofollow" target="_blank">http://eumdr.com/</a> Risk management Standards: ISO 14971 - <a href="https://www.emergobyul.com/services/worldwide/iso-14971-consulting" rel="nofollow" target="_blank">https://www.emergobyul.com/services/worldwide/iso-14971-consulting</a> EU Directory: <a href="https://ubm.box.com/s/2nqk6h7m0r69gb8bp4a3gvx7j16zlm9p" rel="nofollow" target="_blank">https://ubm.box.com/s/2nqk6h7m0r69gb8bp4a3gvx7j16zlm9p</a> FDA: CDRH Guidance: <a href="https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidance-development" rel="nofollow" target="_blank">https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidance-development</a> Searchable product classification: <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm" rel="nofollow" target="_blank">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm</a> FDA Good Guidance Practices: <a href="https://ubm.box.com/s/ejdhq3ta2n8j0jzaod0bb3qjm3bre6pc" rel="nofollow" target="_blank">https://ubm.box.com/s/ejdhq3ta2n8j0jzaod0bb3qjm3bre6pc</a> Funding Resources FDA 510(k) Premarket Submission <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm" rel="nofollow" target="_blank">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm</a> Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers.  After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge.  In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.    Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Part 1 of Get Your Medical Device to Market in 10 Easy Steps: Planning

On today’s episode, Stacey Bruzzese welcomes Felicia Ford-Rice from PAREXEL Consulting to talk the top 3 trending topics in pharmaceuticals – data integrity, AI and leadership. Stacey and Felicia talk about a variety of topics: Felicia talks about the importance of data integrity in pharmaceuticals and why it remains a burning issue How do data integrity and security impact the manufacturing process, operations and clinical environments? What are the pros and cons of pharma adopting artificial intelligence? Where are we in the adoption cycle on AI implementation and how does it look going forward? Will AI help the success rates of drugs passing clinical trials? Are the leadership roles within pharma changing and how so? What skills and strengths will be needed for leaders going forward? What steps do industry leaders need to take to move in the right direction while still emphasizing a patient centric mindset? MIT study - https://academic.oup.com/biostatistics/article/20/2/273/4817524  Felicia Ford-Rice utilizes over 25 years of R&amp;D, Regulatory Affairs and Quality Assurance expertise to advise clients on the development, implementation, and management of quality systems to ensure Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice and Pharmacovigilance compliance. She provides consulting services on a variety of quality compliance topics including: GxP Compliance/ Inspection Readiness / Training, Regulatory Risk/ Data Integrity/Failure Investigation/ Change Control Evaluation, and Corrective Action and Preventive Action /Product Complaint Assessments. She achieved a master’s in Bioscience Regulatory Affairs from Johns Hopkins University, as well as a Master’s of Management in Business Administration and a BS in Biology from Virginia Tech. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

On today’s episode, Stacey Bruzzese welcomes Felicia Ford-Rice from PAREXEL Consulting to talk the top 3 trending topics in pharmaceuticals – data integrity, AI and leadership. Stacey and Felicia talk about a variety of topics: <ul><li>Felicia talks about the importance of data integrity in pharmaceuticals and why it remains a burning issue</li> <li>How do data integrity and security impact the manufacturing process, operations and clinical environments?</li> <li>What are the pros and cons of pharma adopting artificial intelligence?</li> <li>Where are we in the adoption cycle on AI implementation and how does it look going forward?</li> <li>Will AI help the success rates of drugs passing clinical trials?</li> <li>Are the leadership roles within pharma changing and how so?</li> <li>What skills and strengths will be needed for leaders going forward?</li> <li>What steps do industry leaders need to take to move in the right direction while still emphasizing a patient centric mindset?</li> <li>MIT study - <a href="https://academic.oup.com/biostatistics/article/20/2/273/4817524" rel="nofollow" target="_blank">https://academic.oup.com/biostatistics/article/20/2/273/4817524</a></li> </ul> Felicia Ford-Rice utilizes over 25 years of R&amp;D, Regulatory Affairs and Quality Assurance expertise to advise clients on the development, implementation, and management of quality systems to ensure Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice and Pharmacovigilance compliance. She provides consulting services on a variety of quality compliance topics including: GxP Compliance/ Inspection Readiness / Training, Regulatory Risk/ Data Integrity/Failure Investigation/ Change Control Evaluation, and Corrective Action and Preventive Action /Product Complaint Assessments. She achieved a master’s in Bioscience Regulatory Affairs from Johns Hopkins University, as well as a Master’s of Management in Business Administration and a BS in Biology from Virginia Tech. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at <a href="http://ivtnetwork.com" rel="nofollow" target="_blank">http://ivtnetwork.com</a>.

Women in Science, Technology, Engineering and Mathematics – what’s the real deal?

The best podcast episodes on non-current politics. Covering topics such as universal basic income, democracy, poverty & justice and more. For anyone interested in learning more about politics that affect that world, not just now, but in the longer term. Add episodes you're interested into your queue below!

Best Non-Current Politics Podcasts

The best podcasts about ourselves as well as the world through the lense of Science. Specific topics include things about our brain, emotions to biology, physics and more!