Voices In Validation

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 & 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 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 & 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. 

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&J.   About Our Guest: Ron Schardong is privileged to lead Johnson & 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 & 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.     

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 & Risk Tolerance In Pharma & 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. 

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. 

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. 

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. 

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. 

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 & 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&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&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, 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, Stacey is joined by Chinmoy Roy to answer some important questions about the current state of digital transformation across the pharmaceutical industry. Digital transformation in the pharmaceutical industry is crucial for better patient care, cost-effectiveness, greater transparency, improved production, and drug development. Across the pharmaceutical industry, companies are at varying stages in the adoption of digital technologies, but it is clear that the recent COVID pandemic may have accelerated this process for all by about 3 to 4 years. So where are we now as an industry, and what are companies doing to move toward a strategic digital transformation plan?   About Our Guest: Chinmoy Roy is a seasoned Life Sciences professional with 40 years of hands-on and managerial experience in the life sciences industry. He brings extensive implementation experience in engineering, CCSV (Computerized and Cloud Systems Validation), Data Integrity, and IT compliance, providing the foundation for his consulting and training services. His training in CCSV and Data Integrity has been meticulously developed to disseminate the understanding of industry regulations from fundamental principles of science, engineering, and technology. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF, Shimadzu's annual conference for the Asia Pacific, etc. He has worked at or been a consultant for leading US companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson, etc. He has been on Data Integrity discussion panels with FDA inspectors. He travels worldwide to conduct CSV and Data Integrity training. He was one of the early implementors of the world's largest fully paperless manufacturing automation IT system that conforms to 21CFR Part 11 and Data Integrity. He led a team of over 40 engineers and validators to design the system and obtain ‘fit for use' certification in 1999. His pioneering efforts in implementing that system while employed by Genentech was a precursor to the FDA's issuance of Part 11's Scope and Application guidance in 2003.   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, 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 week's episode, we look back at some interesting discussions from the first year in our Risk Revolution series. In these clips, you will hear from series coordinator Nuala Calnan, series regular Lori Richter, Chris Flask, Valerie Mulholland, Amanda McFarland, Rob De La Espriella, and Marty Lipa.  Segment 1 (00:00): The first clip is taken from episode one in the series and features a discussion on the current challenges of QRM.  Segment 2 (07:30): The second clip is taken from the episode "Making Confident Risk-Based  Decisions". In this clip, Lori will help define what Risk-Based decisions truly are.  Segment 3 (15:33): This segment is taken from "Dreading The Risk Life". Amanda McFarland discusses what and why risk can be a dreadful thought for many in the industry. Segment 4 (20:03): This segment, from the "Getting to the Root of the Matter" episode, looks at complex problem solving with guest Rob De La Espriella. Segment 5 (30:45): Finally we hear from Marty Lipa about why QRM and KM ended up as separate processes in the 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.

This week, Kelly Simpliciano hosts a discussion on GXP inspection principles and the changes in processes and expectations stemming from the Covid-19 pandemic. More work than ever is being completed by virtual connections, remote activities, and through systems and processes more reliant on collaborative team efforts and digital technologies. Understanding how these elements affect our inspection preparedness, as well as our day-of-audit activities, is critical to a successful site visit. Be prepared for virtual site visits and audits to become the norm. About Our Guest: Kelly Simpliciano Associate Director, Research Development Quality - Clinical Trials Systems & Auditing QA Bristol-Myers Squibb. Kelly has been with Bristol-Myers Squibb since 2003 when she joined as a QA analyst. Kelly achieved her MS, Quality Assurance and Regulatory Affairs in 2018. 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 episode is brought to you by IVT Network's Validation Week.

This week, Ferdi Steinmann shares his three things you can do to bring intelligence into everything you do. Ferdi breaks down the barriers to intelligence and helps show the path to overcoming the tsunami of data in life sciences. Ferdi covers medical innovations, patient applications, wearables, and the internet of medical things. About Our Guest: Ferdi has nearly 25 years of driving strategy & commercialization efforts in Biotech, Pharma, and Enterprise Software with Fortune 500 Co's such as Merck & Co, Eli Lilly & Biogen. Ferdi's focus is on Life Sciences (LS) strategic planning and industry marketing efforts for enterprise software solutions at OpenText today. He is energized by strategies that deliver on their promises! www.opentext.com www.ivtnetwork.com 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, Alan Golden hosts a comprehensive discussion on the changes driven by risk and conversely risk updates that are driven by change as well as risk integration. Alan will share his expertise from over 30 years in the medical device industry. Alan Golden: Alan Golden is Principal at Design Quality Consultants, LLC where he works with clients training and advising on topics in the medical device industry including Design Control, Change Control, Risk Management, and process/test method validation. Alan has more than 30 years of experience working in the medical device industry. In addition to his expertise in Design Controls, he is also highly experienced in Good Laboratory Practice (GLP), 21 CFR 820, ISO 13485, ISO 14971, Biotechnology, and U.S. Food and Drug Administration (FDA) and risk management. He retired from Abbott Molecular in 2018. 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 episode is brought to you by IVT Network's Validation Week.

In this episode, Stacey is joined by series coordinator Nuala Calnan and regular contributor Valerie Mulholland to discuss the book "Foundations in Quality Risk Management" with the author, Dr. Tim Sandle. One of the key topics of discussion is dealing with "Fuzzy Logic", and how to manage situations that appear vague, and how that applies to the Pharmaceutical and Healthcare industries. 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. Resources from this episode: The ICH Q9 (R1) Guidelines ICH Q9 (R1) Presentation Can Fuzzy Logic Be Applied to Risk Management Critical Thinking #1: Why Pharmaceuticals and Healthcare Needs ... Critical Thinking #2: Reading Research Papers Critical Thinking #3: Developing Questions to Achieve the Optimal ... Risk Management, Knowledge Management and the Risk Knowledge Infinity Cycle on Risk Revolution Risk Revolution - Getting to the Root of the Matter 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.   

In this episode, Stacey is joined by Alex Castro to talk about accepting that bias does exist, and strategies for managing and moving beyond biased decision-making practices. Biases is a very interesting topic, and one that we take very seriously in life science manufacturing, as it can impact the quality of the product and add undue risk in this highly regulated environment. Interestingly, many do not consider their personal biases and their impacts on our decision-making and general ways of thinking. About Our Guest: Alex Castro Alex Castro is an aligner of execution to strategy for digital transformation & innovation, best-selling author, and creator/founder of ReM Score™. Alex believes that the gap between ideas (strategy) and execution is a persistent problem that is sidelining too many high-potential digital transformation and innovation growth opportunities. What will set companies apart in these uncertain economic times are those that reduce the falloff rate of good ideas during execution, seeing more of them create value, resulting in ultimately thriving in the ‘next normal.' Aligning execution to your ideas for digital transformation and innovation is rooted in removing the biases that have us repeating the same errors in estimating our capabilities to execute. There is a way to calculate your execution capability for each idea you have, so more of them come to life, and you and your company win more. Alex is a charismatic, intelligent, and knowledgeable guest, with plenty of wisdom to share.   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 once again by Chris Wubbolt. Stacey and Chris discuss the ins and outs of paper vs. electronic records. In GMP-regulated environments maintaining proper records and documentation is critical to data integrity, regulatory compliance, and GMP best practices. Starting with Part 11 more than two decades ago, we've seen an emphasis on good record keeping and a shift to paperless.  Still, paper-based systems are prevalent around the world, but given our current environment and reliance on digital technologies are we now at a point where the industry is ready to embrace that shift? About our guest: Chris Wubbolt Chris has over 25 years of experience in the 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.

This week, Stacey chats with Rich Forsyth about understanding the results of testing, and reproducibility of test results under varying conditions allows for consistency across teams and lessens the risk of error in cleaning validation activities. Visual inspection of equipment has always been an important element of the cleaning validation program. Establishing visible residue limits is extremely valuable in setting a baseline for cleanliness, highlighting viewing conditions, and defining a methodology for performing routine checks on cleaning validation procedures. Resources for this episode: Richard J. Forsyth; Ruggedness of Visible Residue Limits for Cleaning Validation, April 2, 2016, Pharmaceutical Technology FDA Cleaning Validation Guideline from CFR 211.67 Questions and Answers on Current Good Manufacturing Practices—Equipment EMA Cleaning Validation Guideline on setting HBELs   QnA on the implementation of the above guideline WHO good manufacturing practices for active pharmaceutical ingredients  Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation PIC/s Aide-Memoire: Inspection of Health Based Exposure Limit (HBEL) Assessment and use in Quality Risk Management Health Canada Cleaning Validation Guideline About our guest: Richard Forsyth Rich is responsible for customer support for Cleaning Validation and Cleaning related topics.  He has worked as a consultant for several years and prior to that worked in as Associate Director with Merck & Co. for more than three decades.  He has been involved with Cleaning Validation for over 20 years.  Rich has a broad range of analytical experience including methods development and validation as well as formulation development and project management.  Academic training includes an MS in Chemistry and an MBA in Management, both from St. Joseph's University in Philadelphia, PA. 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 presents the 2021 IVT Awards and interviews the recipients of each award. The awards being presented are Author of the Year for the Journal of GXP Compliance, Author of the Year for the Journal of Validation Technology, Podcast of the Year, Speaker of the Year for Validation Week, Speaker of the Year for Compounding Pharmacy Compliance, Speaker of the Year for Computer Systems Validation and Software Assurance, and the prestigious Chapman Award. During this presentation, you will hear from Ron Schardong, Valarie King-Bailey, Richard Wedlich, Kurt Moyer, Steve Thompson, Dr. Ross Caputo, and Dr. Paul Pluta. The team at IVT Network, together with our Esteemed Advisory Board, are proud to announce the recipients of the 2021 IVT Awards. These annual awards recognize the outstanding authors, speakers, podcast guests, and presenters, who keep our audience informed and forward-thinking. Nominees for the author of the year (both JVT and GXP) are selected by their peers, based on articles published and topics covered, which have been integral to learning and knowledge share across industries throughout the year. The podcast of the year is presented to the individual or panel receiving the greatest number of downloads and listens. Finally, our speakers of the year are selected by vote from attendees of the sessions as the most impactful and engaging in their presentations for the associated event. 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 and Nuala sit down with Jayet Moon, author of "Foundations in Quality Risk Management" to review some of the key discussion points from his book and share his views on how risk management “is central to the science of prediction and decision-making;” and how “holistic and scientific risk management creates resilient organizations, which survive and thrive by being adaptable.” Jayet will also explain how lobsters can live forever.   Resources from this episode: A Quantitative Method for Modelling Copy of SAQI eQE Newsletter Issue 241 - February 2021 Copy of Quality World - Spring 2021 Foundations Of Quality Risk Management: A Practical Approach to Effective Risk-Based Thinking About our guest: Jayet Moon  Jayet has earned a master's degree in biomedical engineering from Drexel University in Philadelphia and is a Project Management Institute (PMI) Certified Risk Management Professional (PMI-RMP). Jayet is also a Chartered Quality Professional in the UK certified by the Chartered Quality Institute (CQI). He is also an Enterprise Risk Management Certified Professional (ERMCP) and a Risk Management Society (RIMS) certified Risk Management Professional (RIMS-CRMP). Jayet was recently awarded the Australian Organization for Quality 'Passion for Excellence' Award and recognized as American Society for Quality '40 under 40' Rising Star in their November 2021 issue of Quality Progress magazine. He is a Fellow of Royal Society for Arts (FRSA) and a Fellow of International Institute for Safety and Risk Management (FIIRSM). He is the author of the book, ‘Foundations of Quality Risk Management' published by ASQ Quality Press, and holds ASQ CQE, CQSP, and CQIA certifications. Popular articles authored by him on Quality and Risk Management have been published in global trade magazines such as Quality Press (USA), Quality World (UK), Quality Business (Australia and New Zealand), QCI Magazine (India), and eQuality Edge (South Africa).   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 Kate Coleman to discuss the essentials for building a culture of quality while achieving customer satisfaction. Across life sciences, teams concur that quality, defined by safe, effective, and compliant products, is a prerequisite of the pharmaceutical, biomedical or medical device industry.  The Quality Management System then provides the basic infrastructure needed for defining and validating the documents, processes, procedures, and systems to meet the company's quality objectives. The bi-product?  ̶  the highest customer and patient satisfaction. Resources from this episode: Overview of the Quality System Regulation - US Food and Drug Guidance for Industry Q10 Pharmaceutical Quality System Can a robust QMS help you achieve customer satisfaction? About Our Guest: Kate Coleman, Senior Director/ Principal Consultant at PharmaLex 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. 

This week, Stacey is joined by Amanda Coogan to discuss the opportunities and challenges of implementing automated clinical trial management solutions using RBM. Given our current environment, it is no surprise that pharma and device companies are doing everything possible to boost efficiencies. Increasing drug development and production in safe and effective ways, while limiting resources used and dollars spent can be a balancing act. This also applies to clinical trials. Adoption of a risk-based monitoring (RBM) approach may be the best method to support clinical studies while keeping an eye on compliance.   Resources from this episode: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring - Guidance for Industry (2013) A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers - Draft Guidance for Industry (2019) Tackling the Challenges of Transitioning to Risk-Based Monitoring   About Our Guest: Amanda Coogan, Senior Customer Partnership Manager, Remarque Systems Amanda spent the first 12 years of her clinical research career in clinical operations for university hospitals and medical device firms supporting domestic and international studies. She then transitioned to the software industry, where she has served for 6 years as a consultant, subject matter expert, and project manager to small and large pharma, medical device, and CRO customers supporting their implementation of Risk-Based Quality Management. In addition to working with customers to optimize their use of technology within their RBQM strategy, she provides clinical trial operation expertise to support software product development. She can be reached at acoogan@remarquesystems.com   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 Bryan Prince to talk about the implementation of the 2019 final version of USP 800, and how it is not currently being enforced by most states but quite a few pharmacies around the country are either in the planning and budgeting phase or have already moved forward with construction and being compliant with USP 800 standards.   Resources from this episode: USP General Chapter Hazardous Drugs regulations Physical Environment Provisions of USP   About our guest: Bryan Prince is the owner and lead consultant at Lab Red Pharmacy Consultants.  His early career consisted of more than a decade in construction before moving to engineered containment serving the pharmaceutical industry and now the compounding industry.  Since 2015 Bryan has designed and consulted on more than a hundred compounding pharmacies working with owners, architects, engineers, and contractors.  Email:  bryan@compoundingworkflow.com  and watch videos http://compoundingworkflow.com   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 Nuala Calnan and Valerie Mulholland for an Ask Me Anything session on Quality Risk Management. Valerie answers questions about ICH Q9, ISO Divergence, ICH Q12, Analytical Lifecycle Management, Quality Management Maturity, and much more. 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. Resources from this episode: QRM: a Case for Convergence Risk-Based Decision Making: PODCAST RECORDING Risk Management, Knowledge Management, and the Risk Understanding the Concept of Formality In Quality Risk Quality Management Maturity – A Pilot Program of the FDA ICH Q9 R1 concept document ICH Q14 Concept Paper 2021 Updated PIC/s Aide-Memoire on Assessment of QRM Implementation Sept 24, 2021, Pre-post version of USP 1220 Chapter on Analytical Procedure Life Cycle   About Our Guest: Valerie Mulholland Valerie Mulholland is the CEO of GMP Services Ltd and is a GMP/Quality Consultant in Europe. She is a practitioner in the area of Quality Risk Management and is researching the topic of Risk-Based Decision Making for a Ph.D. dissertation with the Pharmaceutical Regulatory Science Team in TU Dublin. 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 and industry expert, Chris Wubbolt, count down the top five data integrity issues when complying with GMP guidance. Data Integrity is a critical element to GMP compliance, and all life science manufacturers need to develop and maintain processes for managing their data, reducing the risk to the integrity of that data, and stored properly. Of course, this is all part of the Regulatory Guidelines which have been in place for years. Still, nearly half of all warning letters contain data integrity components. Resources for this Episode: Data Integrity and Compliance with cGMP Guidance Guideline on data integrity - WHO | World Health Organization Part 11, Electronic Records; Electronic Signatures - Scope and Application About Our Guest: Chris Wubbolt, Principal, QACV Consulting Chris has over 25 years of experience in the 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. 

This week, Stacey welcomes back Siegfried Schmitt to the show. Stacey and Siegfried discuss the complexities in supply chain management, the expectations for a GDP audit, and deficiencies in distribution processes. Maintaining product safety and quality during distribution is of utmost importance in the pharmaceutical industry. Just like in other areas of drug manufacture, there is an expected dedication to quality and compliance, which should be present in every aspect of distribution. It is the responsibility of the drug company to comply with distribution requirements including storage and transport of their products, ensuring its safety and security throughout the supply chain.   About Our Guest: Siegfried Schmitt 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 of 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.   For more information or to register for the Compounding Pharmacy Compliance East conference, please visit: https://bit.ly/3yzhlnN   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 Ken Shitamoto to explore critical thinking in the systems validation department and share concepts and case history. Most industry folks have heard about CSA and understand the basics behind the shift in priorities. What's better left to understand is the if's and how's around adoption and implementation within our own organizations. A risk-based approach is nothing new. However, the evolution centers on a risk-based approach using critical thinking, with a focus on assurance needs, testing activities for our higher-risk activities. About our Guest Ken Shitamoto, MS Senor Director, IT, Gilead Sciences Ken leads the IT quality engineering function at Gilead Sciences, which performs software quality assurance (testing), validation, and infrastructure qualification. He is a multi-disciplined professional with extensive experience in quality engineering, quality management, project management, and software development. He has been in the biopharmaceutical space since 1993 and has worked both on the manufacturer, vendor, and consulting sides of the business. Additionally, he has also performed over 100 GXP computer systems compliance audits globally. He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively. He is an avid supporter of the American Lung Association, and Ken and his daughter have raised over 130K dollars to fight lung disease. 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 Renee Phillips to discuss the pros and cons of transitioning to a continuous manufacturing system. Batch production is time-consuming yet remains a popular and time-tested method used in the pharma industry today - but some industry leaders, along with the FDA, have taken steps toward or are now contemplating a shift to continuous manufacturing. This means all stages of drug production run through to the final product, without a stop during its production, thus shut down of equipment between “batches” is required, which eliminates downtime.  CM  saves time and reduces the likelihood of human error, but is it realistic at this point in time? Resources for this episode: FDA issued draft guidance, Quality Considerations for Continuous Manufacturing Rogers, Luke & Jensen, Klavs F. (2019). Continuous manufacturing – the Green Chemistry promise?. The Royal Society of Chemistry. Green Chem., Volume 21, 3481-3498. Moore, Christine M. V., Garcia, Thomas P., Hausner, Douglas B., Ben-Anat, Inna. (2019) Holistic Control Strategies for Continuous Manufacturing. Pharmaceutical Engineering, May/June 2019 Srai, Jagjit Singh., Settani, Ettore., Aulakh, Parminder Kaur., Evaluating the Business Case for Continuous Manufacturing of Pharmaceuticals: A Supply Network Perspective. Continuous Pharmaceutical Processing, June 2020, 477-512 Van Arnum, Patricia. Pharma Industry Weighs in on Continuous Manufacturing. June 19, 2019 Manning, Richard., Sciacca, Rich., Continuous Manufacturing in Pharmaceuticals: Economic and Policy Issues. Bates White Economic Consulting, October 2018 About Our Guest: Renée L. Phillips is an Associate Director of Global Regulatory Affairs at Janssen Research &  Development,  LLC,  a  pharmaceutical company of  Johnson  &  Johnson.  Renée has responsibility for Chemistry Manufacturing & Controls for API's and marketed products. Previously she has held positions in Regulatory Affairs at Johnson & Johnson Consumer Companies,  Wyeth  Consumer  Products,  a  small start-up pharma company, and an environmental chemistry laboratory.  Renée currently serves as an adjunct professor at Temple University School of Pharmacy where she teaches courses in good manufacturing practices and global drug registration requirements. She earned her Bachelor of Science in Biochemistry from Georgian Court College and a Master of Science in Regulatory Affairs from San Diego State University. 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 and Nuala invite a regular IVT contributor and industry disruptor Karen Ginsbury to innovate and revolutionize the future of quality management within the pharmaceutical and biopharmaceutical, and med device sectors. Karen will share her views on ICH Q10 and what must happen next.   Resources from this episode: One Voice of Quality Website One-Voice-of-Quality (1VQ) Solutions Part 2 - Podcast Episode | IVT One-Voice-of-Quality (1VQ) Solutions – an Enhanced Science and ... Elon Musk Hiring Ad What Is Industry 4.0?   About Our Guest: Karen Ginsbury Karen 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. 

In this episode, Stacey is joined by David Nettleton to discuss some of the key topics from the recent CSV Virtual Week panel "CSA Revolution." The session "CSA Revolution" was intended to provide a better understanding of the intent and scope of the FDA's Computer Software Assurance guidance while highlighting CSA's relationship to other existing regulations. David will share his expertise on some of the ideas and concepts shared in the discussion.  About Our Guest: David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), software validation, and computer system validation. He is involved with the development, purchase, installation, operation, and maintenance of computerized systems used in FDA-compliant applications. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. He can be reached at dnettleton@computersystemvalidation.com   For information or to register for Validation Week 2001 visit: VALIDATION WEEK 2021   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. 

In this episode, we will hear an exclusive panel discussion CSV Virtual Event "CSA Revolution." This discussion will provide a better understanding of the intent and scope of the FDA's Computer Software Assurance guidance while highlighting CSA's relationship to other existing regulations. Key concepts of CSA include the push for critical thinking and risk-based principles as part of the lifecycle strategy in support of data integrity, and how CSA promotes better use of data for the benefit of patient safety and product quality. The panelists for this discussion: Senthil Gurumoorthi - Director IT Gilead Sciences Cisco Vicenty - Program Manager Case for Quality FDA Ray Murphy - Principal Engineer Corporate Software Quality Boston Scientific Ken Shitamoto - Senior Director IT Gilead Sciences Khaled Moussally - EVP Clients & Regulatory Relations Compliance Group Inc. 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 Divya Yerraguntla to host a panel discussion on Women in STEM, in partnership with the Woman to Woman podcast. On this panel you will hear conversations about developing an interest in STEM, overcoming barriers in the pursuit of an education in STEM, the obstacles women face when beginning their careers and advancing their careers. The panel takes a look at women's evolving role in STEM and what the future may hold. The panelists on this episode are Erin Russell, Valarie King-Bailey, Barkha Saxena, and Beth Kroeger.  About the panelists: Divya Yerraguntla Divya is the host of the Woman to Woman podcast. Divya is also the Vice President, Asset Strategy for Syneos Health. Divya graduated from the Indian Institute of Technology with a Masters in Applied Mathematics. She completed her MBA in Marketing and Strategic Management from Rutgers University. Barkha Saxena Barkha is currently the Chief Data Officer for Poshmark. Barkha also serves on the Board of Advisors for Pecan AI. Barkha graduated from the Indian Institute of Technology with a BS and MS in Statistics. She also graduated from the University of California at Santa Barbara with a MA in Statistics and completed her MBA in Strategic Management from The Wharton School. Beth Kroeger Beth is a Technical Service Manager. She specializes in cleaning chemistries, processes, and validation. Beth's background includes over 18 years of experience in finished pharmaceutical and upstream and downstream biotech manufacturing. Beth has a B.S. in Biochemistry. Erin Russell Erin is the Founder and CEO of Health Grizzly, a wellness and care navigator helping people find the care they need to improve their health. Erin graduated from Arizona University with a BS in Chemistry. Erin completed her MBA at Harvard Business School.   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.     

In this week's edition of Risk Revolution, Stacey is joined by Nuala Calnan and Marty Lipa to discuss the Risk Knowledge Infinity Cycle. Stacey, Nuala, and Marty also chat about the ways Risk Management and Knowledge Management work together to provide a more effective Quality Management System and the two enablers to building an effective Quality Management System, QRM and KM, which really have been kept separate in the industry but should be working together. Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. This series aims to advance the maturity of risk management practices within the industry, addressing topics that challenge quality professionals to seek opportunities to improve and advance how they perceive and manage risk. Resources from this episode: ISPE's KM Good Practice Guide T.U. Dublin's :  A Survey Report on the Current State of QRM and KM Integration Knowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge Managemen Managing Knowledge and Risk – A Literature Review on the Interdependency of QRM and KM as ICH Q10 Enablers Effective Knowledge Transfer During Biopharmaceutical Technology Transfer Turning Knowledge Into an Asset in Pharmaceuticals – PODCAST   About Our Guest: Marty Lipa Marty Lipa, is the Executive Director - Knowledge Management at Merck.  Marty has over 27 years in the biopharmaceutical industry and has led the KM Center of Excellence for Merck manufacturing for the last 11 years.  Marty has recently completed the requirements for his Ph.D. at TU Dublin with an emphasis KM and its connection to QRM.   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 Dr. Tim Sandle to discuss developing effective contamination control strategies to deal with all aspects of contamination such as particulate, microbial, product carryover, chemical (like cleaning material residues) as well as viral. Dr. Tim Sandle details the common types of contamination, what regulators are seeking from control strategies, the challenges of implementing control strategies, and much more.   Resources for this Episode: Biocontamination Control for Pharmaceuticals and Healthcare, by Tim Sandle EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products (Draft) ISO 14698-1: 2003, Cleanrooms and associated controlled environments FDA Guidelines on Contamination Control Sterile Drug Products Produced by Aseptic Processing 〈797〉 Pharmaceutical Compounding—Sterile ... - USP   About Our Guest: Dr. Tim Sandle Ph.D. is a pharmaceutical microbiologist, with over 25 years of experience, who has worked for different healthcare organizations and pharmaceutical companies, in microbiology and broader quality roles. Dr. Sandle currently works for an international sterile products manufacturer and he is additionally a visiting tutor with the University of Manchester (lecturing in pharmaceutical microbiology), a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig), and a supporter of several other societies relating to pharmaceuticals and healthcare, including IVT. Dr. Sandle also serves on several advisory committees and standards boards. Dr. Sandle has written or edited over 25 books, more than 100 book chapters, 125 peer-reviewed papers, and some 400 technical articles. Dr. Sandle is a regular presenter at conferences and webinars, having delivered over 150 presentations.   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. 

In this episode, Stacey is joined by Steve Thompson to discuss some of the key topics from the recent CSV panel on "Digital Transformation Initiative." The panel shared first-hand experiences of point solutions, and platform transitions, as well as lessons learned from migration to cloud computing and cloud first approaches. Steve will share his expertise on some of the ideas and concepts shared in the discussion.  About Our Guest: Steve Thompson has over 20 years of experience in life science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies, including biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers. He is a published author, was certified as a PDA Systems Auditor in 2003 and is a regular speaker on industry trends and best practices. Steve received a Bachelor of Science, Computer Information Systems, degree in 1986. He can be reached at steven.thompson@valgenesis.com     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. 

In this episode, we will hear an exclusive conversation from the recent CSV Virtual Event, "Digital Transformation Initiative" This discussion was moderated by Daniel Matlis and features Sam Cheemokati, Paul Hurlocker, and Ron Schardong.  The discussion will be focused on exploring organization-wide digital transformation initiatives. The panel will share their firsthand experiences of point solutions to platforms transitions. And, the best practices when shifting to cloud computing and the cloud-first approach. About the panel: Daniel Matlis Daniel R. Matlis is the Founder and President of Axendia – a trusted advisor to Life-Science and Healthcare executives on business, technology, and regulatory issues. Dan's career in the industry spans over 20-years and has included projects in research & development, manufacturing, regulatory compliance, business development and information technology. Prior to founding Axendia, Dan was General Manager & VP at Stelex (now a GE company) – a leading consultancy to life-science companies. He started his professional career at Ethicon, Inc., a Johnson & Johnson Company.   Sam Cheemakoti Sam is the GMP Head at Beiersdorf for the Coppertone Division overseeing GMP compliance of its computer and automated systems. Sam has held positions of increasing responsibility at various Pharmaceutical companies such as Bayer, Merck, and Schering Plough in the areas of Computer Systems Validation, IT Compliance, and Quality Assurance. As a Quality leader with 20+ years in the industry with a demonstrated ability to produce and deploy Part 11 and Data Integrity remediation programs, validation programs, quality systems, strategic initiatives for Quality and Compliance especially under conditions of the consent decree, acquisitions, and divestitures has lent him unique perspectives as a change ambassador and thought leader. Sam earned his MS in Industrial Engineering from Louisiana Tech University and his Project Management credentials from Villanova University. He more recently completed a course on Digital Transformation: Leading People, Data and Technology from the University of Berkeley under their Executive Education Program in order to gain synergies between the two journeys of Digital Transformation and Computer Software Assurance for Quality.    Paul Hurlocker Paul is the CTO at Spring Oaks Capital, a technology-driven financial services company whose mission is to reinvent the debt recovery industry by providing a customer-centered user experience and streamlined operations powered by data and machine learning. Paul previously served as the Senior Director and Vice President of the Center for Machine Learning for Capital One. Paul founded Notch, Co and served as the CEO before selling the company to Capital One. Ron Schardong Ron is privileged to lead Johnson & Johnson's Technology Quality group responsible for computerized systems validation of business applications in the Medical Devices, Consumer, and Pharmaceutical segments worldwide. The applications include ERP, Warehouse Management, Manufacturing, Laboratory, Quality Systems, Clinical, R&D, Enterprise Tools, Services, and Infrastructure. He has over 25 years of experience in quality engineering, supplier quality, quality auditing, quality management, regulatory compliance, and regulatory affairs. Ron is one of the original members of FICSA Group (FDA + Industry Computer Assurance Group).   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 Robin Toft to talk about the challenges of attracting and hiring top talent, tactics for building and retaining a workforce, and the technologies that are changing the ways we recruit, hire, and train our teams. Stacey and Robin also discuss which areas are in the most demand, talent management strategies, career path planning, and much more. Resources from this episode: Talent 2020: Surveying The Talent Paradox From The Employee Perspective: The View From The Life Sciences Sector https://www2.deloitte.com/content/dam/Deloitte/mx/Documents/human-capital/Talent_2020_LifeSciences.pdf WE CAN: The Executive Woman's Guide to Career – on Amazon https://www.amazon.com/WE-CAN-Executive-Womans-Advancement/dp/1949635031 WE CAN: The Executive Woman's Guide to Career – on Goodreads https://www.goodreads.com/book/show/43533323-we-can We Can Rise Community https://wecanrisecommunity.com/ About Our Guest: Robin Toft is the founder and CEO of Toft Group a ZRG Company, where she combines a deep inside knowledge of the life science industry with a passion for building game-changing management teams. A champion of diverse executive teams, Robin has built a reputation for recruiting women and minorities into top roles and helping the life science industry overcome unconscious bias in hiring. Having successfully sold Toft Group to ZRG Partners, Robin co-founded We Can Rise in 2020, a B-corporation aimed at helping aspiring female executives to confidently reach their potential while achieving balance and collaborating to build healthier companies that change the world. Prior to founding Toft Group in 2010, Robin served 20+ years as a biotech executive. Robin's first book entitled WE CAN, The Executive Woman's Guide to Career Advancement, is recognized within the list of 100 Best CEO Books of All Time by BookAuthority and won Gold for Best E-book in the International Business Awards. In the American Business Awards for 2020, Robin won Gold in the three major individual categories of Lifetime Achievement, Maverick of the Year, and Woman of the Year. She also won Gold for Most Innovative Woman of the Year in the Women in Business Awards for 2020. Robin currently serves on the boards of T2 Biosystems, Syapse, California Life Science Association (CLSA), The Clearity Foundation, and LEAD San Diego. Robin holds a B.S. in Medical Technology from Michigan State. 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 our series coordinators, Lori and Nuala, invite their guest Amanda McFarland to chat about Living the Risk Life. How do we take our colleagues on a journey from dreading their participation in the risk process to actually living a work-life and culture that embraces risk management? Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. This series aims to advance the maturity of risk management practices within the industry, addressing topics that challenge quality professionals to seek opportunities to improve and advance how they perceive and manage risk. Resources from this episode: 12 Inclusive Behaviors - The Kaleel Jamison Consulting How To Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis Amy Edmondson – TED TALK, Psychological Safety About Our Guest: Amanda McFarland - Senior Consultant at Valsource Amanda assists companies with the design and implementation of CGMPs, Microbiology, and Quality Risk Management programs. Amanda specializes in creating and implementing risk management training programs, developing custom risk-based strategies, and risk facilitation.   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.   

In this episode, Stacey is joined by Valarie King-Bailey to discuss some of the key topics from the recent CSV panel on "Excellence and Next-Generation Approaches to Quality System Monitoring." The panel provided reflections on the current landscape, team challenges in data governance programs and policies, understanding sources of bad data, missing data, data consistency and data integrity, as well as the speed of data delivery and defining metrics, and help in establishing digitally-enabled facilities using real-time analytics for agility in meeting ever-changing markets, and leveraging predictive capabilities to ensure highest levels of quality and control. Valarie will share his perspective on these topics as an industry expert.  About our Guest Valarie King-Bailey is the CEO of OnShore Technology Group, an independent Chicago-based consultancy specializing in Independent Validation and Verification (IV&V) products, and solutions.  OnShore's product, ValidationMaster™ is the first fully integrated Enterprise Validation Management system on the market.  ValidationMaster™ was recognized by CIO Review Magazine as one of the top 20 most promising technologies for life sciences in 2015. OnShore led the development of the first FDA Validation Toolkit for Microsoft Dynamics AX and Microsoft NAV. Valarie has worked for leading global companies such as QUMAS Limited (Ireland), EMC/Documentum, Abbott Laboratories, and U.S. Steel – South Works.  At QUMAS, an Irish-based software company, she served as Chief Marketing Officer. She was responsible for all global tactical and strategic marketing initiatives and the development of their validation toolkit.  Valarie founded OnShore Technology Group in 2004.  OnShore Technology Group recently won the American Express/Count Me In M3 Award and the Madam C.J. Walker Outstanding Business Award (2008).   She also received a nomination for the Ernst & Young Entrepreneur of the Year award in 2006. Ms. King- Bailey holds an M.B.A. in Information Systems from Keller Graduate School of Management (1985) and a B.S. in Civil and Environmental Engineering from Wisconsin–M Madison (1982).   She is a member of the American Society of Civil Engineers, Society of Women Engineers, National Girls Collaborative Project for STEM education, Regulatory Affairs Professional Society (RAPS), and a U.W. College of Civil Engineering Advisory Board Member. She can be reached at vkbailey@onshoretech.com  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.     

In this episode, we will hear an exclusive conversation from the recent CSV Virtual Event, "Excellence and Next-Generation Approaches to Quality System Monitoring." This discussion was moderated by Michelle Miller and features Nuala Calnan, Alyce Deegan, and Daniel Caparros. The discussion will be focused on providing reflections on the current landscape, team challenges in data governance programs and policies, understanding sources of bad data, missing data, data consistency and data integrity, as well as the speed of data delivery and defining metrics, and help in establishing digitally-enabled facilities using real-time analytics for agility in meeting ever-changing markets, and leveraging predictive capabilities to ensure highest levels of quality and control. About the panel: Michelle Miller Michelle Miller is Director of Global Validation at Illumina Inc. In this role, Michelle leads the global non-product validation across the company. This includes the strategy and execution of validation for facilities, manufacturing processes, consumables production, quality system, enterprise software, and other systems across all of Illumina. Over the past 12+ years, she has held roles in product engineering, product transfer, validation engineering, and quality assurance, supporting the manufacturing of microarrays, genome sequencing reagents, and consumables. Nuala Calnan Nuala is a 25 year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) on patient safety and product quality. Nuala works with organizations to transform organizational culture, deliver more effective end-to-end risk management, implement knowledge excellence strategies, behavior-based good data governance, and enhance performance management through people. Nuala co-leads the ISPE Quality Culture Team, is a founding member of the ISPE Knowledge Management Task Team, and an Arnold F. Graves Scholar at TU Dublin, Ireland, where she leads many patient-focused regulatory science research projects at Masters and Ph.D. level. Alyce Deegan Alyce has over 20 years of experience in the Pharmaceutical, Medical Device, and Gene Therapy industries. Alyce recently was the CSV Director at SeaGen and 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 Pfizer, Biogen, and ThermoFisher. Daniel Caparros Head of Global Quality Strategy Data and Vendor Management at Merck KGaA, Darmstadt, Germany   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 FDA members Jennifer Maguire, Nandini Rakala, Alex Viehmann, Carla Lundi, and Lyle Canida. Stacey and the team from the FDA discuss the FDA announced innovative Quality Management Maturity Pilot Programs for Manufacturers of Drug Products and Active Pharmaceutical Ingredients. Results of this pilot program are intended to aid in the creation of a future rating system for drug makers, ranking the maturity of their quality management systems. Such a rating system and associated incentives for mature rating could lead to a renewed effort in risk management and provide motivation for companies to invest in their QRMs and the resources surrounding them.   Resources from this episode: Pharmaceutical Quality for the 21st-century report Quality Management Maturity Pilot Program as announced by the FDA   About Our Guests: CDR Lyle Canida CDR Lyle Canida is a PHS officer with 11 years at FDA. He has a Pharm.D., M.S. in Pharmacoepidemiology, and is Certified in Public Health. During his time with FDA, he has worked in various roles including IND and NDA reviews for clinical pharmacology genomics and overseeing post-market safety programs for drugs, foods, cosmetics, and dietary supplements. More recently, he has been with the Office of Pharmaceutical Quality helping to drive quality surveillance programs and other strategic initiatives. Jennifer Maguire, Ph.D. Dr. Jennifer Maguire is the Deputy Director of the Office of Quality Surveillance/OPQ/CDER/FDA. The office assesses intelligence throughout the product lifecycle to inform stakeholders about the state of pharmaceutical quality and uses data analytics to drive surveillance decisions. During her tenure at the agency, Dr. Maguire has contributed to multiple initiatives aimed at modernizing the regulation of pharmaceutical manufacturing and product quality including QbR, QbD, ICH Q12, Site Selection Model, Quality Metrics, and Quality Management Maturity. Dr. Maguire has a BS in Chemical Engineering from the University of Virginia and a Ph.D. in Industrial and Physical Pharmacy from Purdue University. Nandini Rakala, Ph.D. Dr. Nandini Rakala is a Data Scientist and Mathematician by background, currently working as a Visiting Associate within the Center for Drug Evaluation and Research at the U.S. FDA. Dr. Rakala earned her Ph.D. in Operations Research in May 2020, from the Department of Mathematical Sciences at Florida Tech, with her primary research work in Optimization and Machine Learning. She also holds a master's degree in Applied Mathematics and Computing from Manipal University, India; and a bachelor's degree in Mathematics Honors from the Sri Sathya Sai Institute of Higher Learning, India. During her past 2.5 years with the FDA, Dr. Rakala has worked on multidisciplinary regulatory research projects, employing her expertise in operations research, machine learning, natural language processing, programming skills, and knowledge of efficient quality management practices regarding pharmaceutical manufacturing. She is currently leading and/or serving as a subject matter expert on critical OPQ pilot programs such as the Quality Management Maturity, Quality Metrics, predictive modeling of PQS-CAPA effectiveness, prioritization of Field Alert Reports, drug shortage analysis, Report on the State of Pharmaceutical Quality, quality signal detection and topic modeling of post-market surveillance data. Dr. Rakala has had an opportunity to present her research work on several occasions at various conference seminars, and she is a recipient of numerous prestigious awards. In her personal free time, Nandini enjoys volunteering in community service activities, serving as a judge, playing tennis, writing, reading articles, and biographies. Alex Viehmann Alex Viehmann is currently the Director for the Division of Quality Intelligence II within the Office of Pharmaceutical Quality/Office of Quality Surveillance.  The Division performs post-market quality-based assessments of drug sites and products, enhanced by data integration and analytics tools developed in support of monitoring and improving drug quality, to inform congressional inquiries and data calls, future GMP inspections, enforcement decisions, and application assessment.  Alex joined the FDA in May 2008 as an Operations Research Analyst in the Policy and Standards Development staff within the Office of Pharmaceutical Sciences where he collaborated with stakeholders on developing policy and standards on sampling, test method evaluation, and statistical quality control.  He then transitioned to the Science and Research staff where he provided statistical support for CMC review, GMP inspections, and enforcement actions.  Since joining OQS in 2015, Alex has guided the development of OPQ's Quality Metrics program, CDER/ORA's New Inspection Protocol Project (NIPP), and OQS's analytics and modeling program.  He is also actively engaged in implementing Pharmaceutical Quality System (PQS) assessments in support of Established Conditions and the Site Engagement Program (SEP).  He currently serves as the Regulatory Chair for ICH Q9 and as a member of the PIC/S Expert Circle Working Group on Quality Risk Management. Alex received his bachelor's degree in economics from the University of Maryland at College Park.  Carla Lundi Carla J. Lundi has been with the FDA as a Consumer Safety Officer since 2002, working initially with the Office of Regulatory Affairs in the Los Angeles District. While with ORA she was a Drug Specialist, member of the Pharmaceutical Inspectorate, and member of the Drug Foreign Inspection Cadre specializing in sterile drug manufacturing inspections. In 2016 she transferred to CDER's Office of Pharmaceutical Quality, Office of Quality Surveillance working primarily on monitoring drug product and manufacturing site quality-related signals for mitigation of urgent quality issues; evaluation and reporting of data related to pharmaceutical quality and drug availability for internal and external customers; collaborating with business partners to determine data to be collected from sites through onsite inspections or other innovative approaches; and drug training collaboration and development. 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 welcomes back Nuala Calnan and Lori Richter for another episode in the Risk Revolution series. In this episode, we discuss the importance of facilitation in the risk management process and how it leads to the success of a risk assessment. Joining in on this conversation is Tiff Baker, Senior Consultant from ValSource.   Resources in this episode: Humble Inquiry - The Gentle Art of Asking Instead of Telling Building Positive Relationships and Better Organizations, (2021) Edgar Schein The Surprising Power of Questions HBR Bias, Heuristics & Risk (Pt. 1) on Risk Revolution | IVT Bias, Heuristics & Risk (Pt. 2) on Risk Revolution | IVT   About Our Speakers Lori Richter Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx, she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada, and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a Ph.D. at Technological University Dublin. Nuala Calnan –  Nuala is a 25-year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end risk management, implementing knowledge excellence strategies, behavior-based good data governance and enhancing performance management through people. Nuala co-leads the ISPE Quality Culture Team and is a founding member of the ISPE/PQLI Task Team on Knowledge Management. She is also the Arnold F. Graves Scholar with the  Pharmaceutical Regulatory Science Team at TU Dublin, Ireland, where she leads a number of patient-focused regulatory science research projects at the Masters and Ph.D. levels.   Tiff Baker –  Tiff Baker, is a Senior Consultant at Valsource.  Tiff has been working full time in the QRM space for over ten years, and in micro roles within the industry prior to that.  She has implemented QRM programs for companies internationally, delivered risk training to industry and regulators alike, developed custom risk tools to meet client needs, and facilitated many risk assessments over the years.  She is a co-lead for the Parenteral Drug Association's Remote Audits and Inspections Task Force as well as an instructor for the PDA Training and Research Institute.  In addition, Tiff contributed as an author to ISPE's Baseline Guide 5 for Commissioning and Qualification to incorporate risk as well as several Points to Consider documents for the PDA.   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 Paul Pluta and Karen Zimm to discuss the particulars of the drug naming process, definitions, and categories for drug names. Karen and Paul present case study scenarios where drug name communications have led to adverse events.  A drug may be known by different names during its development and commercial lifecycle. Medication safety problems associated with drug names have long been recognized as a significant problem by healthcare professionals. Whether it's look alike or sound alike errors, drug modifier misidentification, or proprietary vs. non-proprietary names, confusion may lead to medication errors – which of course can have fatal effects on patients and consumers. Resources for this Episode: Articles: Medication Safety: Industry Considerations Part 1 - Problem Overview https://www.ivtnetwork.com/article/medication-safety-industry-considerations-part-1-problem-overview  Regulatory 101: Medication Safety - Industry Considerations, Part 2, Drug Names https://www.ivtnetwork.com/article/regulatory-101-medication-safety-industry-considerations-part-2-drug-names Regulatory 101: Drug Name Modifiers – Definition, Categories, Generics, And CAPA https://www.ivtnetwork.com/article/regulatory-101-drug-name-modifiers-%E2%80%93-definition-categories-generics-and-capa Regulatory 101: Biologic Non-Proprietary Drug Names – Terminology And Format https://www.ivtnetwork.com/article/regulatory-101-biologic-non-proprietary-drug-names-%E2%80%93-terminology-and-format  Medication Safety And Drug Names - Valproic Acid Product Problems https://www.ivtnetwork.com/article/medication-safety-and-drug-names-valproic-acid-product-problems References: FDA.  Guidance for Industry.  Best Practices in Developing Proprietary Names for Drugs. https://www.fda.gov/media/88496/download  FDA.  Contents of a Complete Submission for the Evaluation of Proprietary Names.  https://www.fda.gov/media/72144/download  FDA.  Safety Considerations for Product Design to Minimize Medication Errors.  https://www.fda.gov/media/84903/download  FDA. Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.  https://www.fda.gov/media/85879/download  Medicines & Healthcare products Regulatory Agency (UK MHRA).  MHRA Guideline for the Naming of Medicinal Products and Braille Requirements for Name on Label. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/810914/MHRA_Guideline_for_the_Naming_of_Medicinal_Products_and_Braille_Requirements_for_Name_on_Label.pdf.%C2%A0 European Medicines Agency (EMA).  Guideline on the acceptability of names for human medicinal products processed through the centralized  procedure. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf. Health Canada.  Guidance Document for Industry.  Review of Drug Brand Names.  https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-document-industry-review-drug-brand-names.html Health Product Regulatory Authority (Ireland).  Guide to Invented Names of Human Medicines.  file:///D:/HPRA%20Drug%20names.pdf.  To Err is Human:  Building a Safer Health System.  Institute of Medicine, National Academic Press, Washington, DC, 2000.  https://www.ncbi.nlm.nih.gov/books/NBK225182  Preventing Medication Errors.  Institute of Medicine.  National Academic Press., Washington, DC, 2007. https://www.nap.edu/catalog/11623/preventing-medication-errors  Karen R. Zimm, Ph.D.  Karen is currently an Associate Director in Global Regulatory Affairs for Johnson & Johnson Pharmaceutical Research and Development with responsibility for Chemistry Manufacturing & Controls for API's and marketed products. Previously she has held positions in technical operations with Pharmaceutical Sourcing Group – Americas, a division of Ortho-McNeil Pharmaceutical and research & development for the R.W. Johnson Pharmaceutical Research Institute and Whitehall Robins Healthcare (Wyeth Consumer Products). She earned her Bachelor of Science in Pharmacy and PhD in Pharmaceutics under Dr Joseph Schwartz from the Philadelphia College of Pharmacy and Science, MBA in Pharmaceutical Management from Drexel University, and the MS in Quality Assurance/Regulatory Affairs from Temple University. In addition she is a licensed pharmacist and an adjunct professor for the School of Pharmacy/Quality Assurance-Regulatory Affairs at Temple University in Philadelphia, PA. Paul L. Pluta, Ph.D. Paul is a pharmaceutical scientist with technical development, manufacturing, and management experience. He has been involved in nearly all phases of pharmaceutical development and manufacturing including R&D formulation and process development, dissolution, stability, regulatory, quality assurance/control, compliance, specifications, scale-up, technology transfer, technical support, and validation/qualification. In his time at Abbott he had numerous new product and supporting regulatory submissions, as well as, extensive product technical support experience. Additionally, his validation experience includes manufacturing process validation, cleaning validation, and associated systems qualification including aseptic systems. He was also a practicing pharmacist for many years in community and hospital environments with direct involvement in preventing medication errors. He may be reached at paul.pluta@comcast.net. 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 Roberta Goode, who will moderate a discussion on Combination Product Development and some of the challenges that arise in the process. Stacey and Roberta are joined by panelists Becky Leibowitz from Janssen, Kurt Moyer from Pine Lake Laboratories, and Alan Golden from Design Quality Consultants.   Resource from this episode: EU Medical Device General Safety and Performance Guidance – MDR ANNEX 1 Guidance FDA 21 CFR Part 4 – Subpart A – Current GMP for Combo Products FDA 21 CFR Part 4 – Subpart B Post-marketing Safety Reporting for Combo Products ICH Q9 QRM Guidance ISO 10993 – 2018 ISO 11607 Sterile Barrier ABOUT OUR GUESTS: ROBERTA GOODE - Moderator Roberta Goode is an executive with over 25 years of experience in the medical device industry. She is currently President and CEO of Goode Compliance International, a global leader in engineering and compliance services for medical device manufacturers, specializing in process validation, design control and risk management. Prior to founding GCI's medical device division in 1993, Ms. Goode held positions of increasing responsibility in R&D, Manufacturing and Quality Engineering at Beckman-Coulter Corporation, Althin Medical, Inc. (acquired by Baxter Healthcare), and Cordis Corporation (a Johnson and Johnson company), where she contributed intellectual property in the form of four US patents for percutaneous cardiovascular interventional devices. She holds a Master of Science degree in Biomedical Engineering and a Bachelor of Science degree from the University of Miami. Additionally, Ms. Goode has an adjunct faculty appointment at the University of Miami's College of Engineering and is an ASQ Certified Quality Engineer. ALAN GOLDEN – Panelist Alan Golden is Principal at Design Quality Consultants, LLC where he works with clients training and advising on topics in the medical device industry including Design Control, Change Control, Risk Management and process/test method validation. Alan has more than 30 years' experience working in the medical device industry. In addition to his expertise in Design Controls, he is also highly experienced in Good Laboratory Practice (GLP), 21 CFR 820, ISO 13485, ISO 14971, Biotechnology, and U.S. Food and Drug Administration (FDA) and risk management. He retired from Abbott Molecular in 2018. He can be reached at alangolden.dqc@gmail.com  BECKY LEIBOWITZ - Panelist Becky Leibowitz is Director of CMC Regulatory Affairs at Janssen and leads a team of regulatory professionals responsible for developing innovative CMC regulatory strategies for global drug-device combination product clinical trial and marketing applications.  At Janssen, Becky has been responsible for the device-specific sections of US and ROW regulatory submissions for single entity and co-packaged combination products, for new products in development and for post-approval changes.  Prior to Janssen, Becky developed biologic-device combination products and medical devices at ETHICON.  Becky holds both a BS and PhD in Mechanical Engineering. KURT L. MOYER – Panelist Kurt L. Moyer, Ph.D. is currently the President of Pine Lake Laboratories and was the General Manager of Pine Lake Laboratories predecessor NSF Health Sciences for over 10 years. Prior to joining NSF Health Sciences, Dr. Moyer served as a Senior Research Investigator for Sanofi Aventis and a Research Scientist for the DuPont Pharmaceutical Company. Dr. Moyer holds a Ph.D. in Biochemistry from Villanova University and a BS in Biochemistry from Millersville State University. He may be contacted at kmoyer@pinelakelabs.com or at 860-940-6550. He can be reached at kmoyer@pinelakelabs.com   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 welcomes back Ivan Soto to discuss how the pandemic has impacted all businesses in the pharmaceutical and biotechnology industry across every functional area including validation. Downtime due to social distancing requirements, employee illness, and the close of many departments for on-site purposes have had a major impact on productivity and production. Although most companies in the industry have Business Continuity Plans, most of them were not detailed or inclusive enough to provide contingencies for all impacted functional areas. Today we will highlight strategies that enable validation leadership and teams to keep validation activities functional and productive not only throughout but following the pandemic. Resources from this episode: Keeping Validation Functional & Productive During A Pandemic - Article in Journal of Validation Technology, Vol. 26, Issue 6, December 2020 Placing Patient Safety First: Developing A Disaster Plan To Reduce Risks From Covid-19 Stability Program Impacts - Article in Journal of Validation Technology, Vol. 26, Issue 4, August 2020 Ivan Soto is the Director CQV at Emergent BioSolutions, he is responsible for leading the commissioning, qualification, and validation activities at the Canton Massachusetts manufacturing facility. He has been in the industry for over 20 years and has held several technical and management positions at different biotech and pharmaceutical companies in Validation, IT Compliance, Quality Control, Quality Assurance, Manufacturing, and Business Strategy. Ivan is also a contributing editor for the Journal of GxP Compliance and Journal of Validation Technology. He has a B.S. in Chemistry from the Pontifical 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.  Disclaimer: The views expressed in this podcast are those of the guest alone and do not represent the views of Emergent BioSolutions.  

This week, Stacey is joined by Nuala Calnan and Lori Richter to continue their series on Risk Revolution. Rob De La Espriella joins the show to share his insights and expertise on the need for critical thinking and complex problem-solving skills in getting to the root of the matter when we investigate, correct, and prevent failures. Resources from this episode: Root Cause Analysis – A Systematic Approach, JVT Article https://www.ivtnetwork.com/article/root-cause-analysis-%E2%80%93-systematic-approach Addressing the Root Cause, Not the Symptoms: Root Cause Investigations for CAPA – Podcast - https://www.ivtnetwork.com/article/addressing-root-cause-not-symptoms-root-cause-investigations-capa Getting to the Root of the Cause – BioPharm International article - http://www.ivtnetwork.com/sites/default/files/PRE PUB__BP0521_Getting to the root of the matter.pdf   Rob De La Espriella is a former nuclear submarine officer and the founder/owner of DLE Technical Services, LLC (DLE), and DLE has been a prime contractor for the Department of Energy since 2012. Rob is one of the leading experts in causal analysis, with over 30 years of experience in leading and facilitating root cause analyses, event investigations, and assessments at commercial nuclear power plants, the US Nuclear Regulatory Commission (NRC), the DOE, the US Department of Defense (DOD), and Engineering firms. 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 welcomes back Chris Wubbolt to get a better understanding of the unique data integrity and validation oversight needed in virtual environments in a post-pandemic world. Stacey and Chris discuss the challenges for businesses of all sizes whether they use a hybrid or remote model. Resources From This Episode: FDA Provides Guidance on Remote Interactive Evaluations COVID-19 - US Food and Drug Administration Guidelines IVT's Annual Computer Systems Validation and Software Assurance Week Compendia Chris Wubbolt, Principal, QACV Consulting Chris has provided quality assurance and computer validation consulting services since 2001, specializing in validation of computerized systems, as well as quality assurance activities such as auditing, training, and quality improvement processes. Prior to becoming a consultant, Chris worked in Computer Systems Validation and Quality Assurance roles for Aventis Pasteur, Johnson & Johnson’s McNeil Consumer Products Company, and Lancaster Laboratories. He was a contributing member of the GAMP Laboratory Systems Special Interest Group, which published a guidance document on validation of laboratory systems, as well as a chapter chair for the DIA committee developing guidance on computerized systems used in clinical research. Chris can be reached by email at Chris Wubbolt chris.wubbolt@QACVConsulting.com. 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 Chris Flask and they discuss how covid has impacted the drug supply chain, how the drug supply chain will look as we return to normal operations, and what the future has in store for this part of the industry. Resources for this Episode: 1. New Bill Enacted Requiring Forecasting of Medical Device and Supply Shortages 2. FDA Drug Product Tracing Requirements – Overview 3. FDA Drug Product Tracing Requirements – The Bill   Chris Flask, Global Business Capability Owner, Roche Warehousing With over 20 years in Pharma, Chris has held a variety of roles in Manufacturing, Strategic Development, and Supply Chain. All of these roles have required the development of Business Continuity Plans to ensure the continued supply of critical medicines to patients across the globe. Prior to his current role, Chris led the North America hub warehouse for Roche Drug Substance, managing the flow of $40 billion dollars worth of product annually. Chris is currently the Global Business Capability Owner for Roche Warehousing. In this role, Chris is responsible for aligning the business processes used by over 60 warehouses worldwide. Chris holds a bachelor’s degree in Biochemistry from UCLA and a Master’s in Business Administration from UC Davis. Chris is a Black Belt in Lean/Six Sigma methodology and is Certified in Production Inventory Management by APICS. 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 Karen Ginsbury to chat about the guidances available for the Quality Management System, the progression of regulatory guidance and expectations, whether or not they are helping or hindering the process, and how we can move forward with risk-based critical thinking. Karen 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, Stacey welcomes back Ivan Soto, to discuss strategies that enable the implementation of a risk-based change management process. Utilizing a risk-based lifecycle approach to manufacturing allows us to identify, analyze, understand, manage and report any risk, or potential risk throughout the lifecycle. When it comes to change control, it can be much more challenging to apply risk-based methods. Ivan Soto is the Director CQV at Emergent BioSolutions, he is responsible for leading the commissioning, qualification, and validation activities at the Canton Massachusetts manufacturing facility. He has been in the industry for over 20 years and held several technical and management positions at different biotech and pharmaceutical companies in the areas of Validation, IT Compliance, Quality Control, and Quality Assurance, Manufacturing, and Business Strategy. Ivan is also a contributing editor for the Journal of GxP Compliance and Journal of Validation Technology. He has a B.S. in Chemistry from the Pontifical Catholic University of Puerto Rico. Disclaimer: The views expressed in this podcast are those of the guest alone and do not represent the views of Emergent BioSolutions. Resources: https://www.ivtnetwork.com/article/streamlining-change-control-implementing-risk-based-change-management-process https://www.fda.gov/media/85281/download https://picscheme.org/docview/3817 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.