Listen Now

This week, Stacey is joined by Roberta Goode to talk about patient safety and how medical packaging is a key component of that. Stacey and Roberta discuss the nuts & bolts around “Selecting medical device packaging materials and sterilization methods to achieve appropriate sterility assurance levels and sterile barrier integrity throughout the labeled shelf life.” Resources from this episode: ISO 14971:2019 Medical devices – Application of risk management to medical devices - https://www.iso.org/standard/72704.html ISO 24971:2020 Medical devices – Guidance on the application of ISO 14971 - https://www.iso.org/standard/74437.html ISO 11607:2019 Packaging for terminally sterilized medical devices - https://www.iso.org/standard/70799.html ISO 13485:2016 Quality Management System for medical devices - https://www.iso.org/standard/59752.html 21 CFR 820 Quality System Regulation - https://www.govinfo.gov/app/details/CFR-2011-title21-vol8/CFR-2011-title21-vol8-part820 ASTM D4169 -16: Standard Practice for Performance Testing of Shipping Containers and System - https://www.astm.org/DATABASE.CART/HISTORICAL/D4169-09.htm ISTA 2a: Partial Simulation Performance Tests - https://ista.org/test_procedures.php Roberta Goode, Principal, Altrec Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge. In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Today Stacey Bruzzese is joined by guest Rick Rhoads to discuss lessons learned in performing stability tests. Traditionally, compounding pharmacists have relied on professional experience and published data to determine product stability. Based on this knowledge, compounders have extended beyond use dates when deemed safe and effective. With rapidly changing guidelines, these kinds of judgement calls are no longer allowable. Many compounders are forced to conduct expensive and time consuming stability studies to extend the BUDs for compounded sterile preparations. • Article: Lessons Learned from a Trimix Stability Study in 503A Compounding Pharmacy by Rick Rhoads, PharmD. • USP Stakeholder Engagement Plan for Beyond Use Dates (795) (797) • USP Review Perspective on Pharmaceutical Quality • Historical: Beyond use date (BUD) refers to the date or time after which a compounded sterile/non-sterile preparation • May not be stored and based on the original date of compounding. BUDs help decrease the risks to patients cause by physical or chemical degradation, microbial contamination and proliferation, and impact on the integrity of the product and it’s container. Compounding Pharmacist are faced with several challenges surrounding BUDs including, varying regulations from state to state, lack of stability testing on compounded preparation, lack of prior knowledge or experience with either the components of a compound, or the compounded preparation and many instabilities cannot be detected without the use of analytic equipment. 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, will engage their guest Valerie Mulholland in a lively discussion on a critical aspect of Risk Management, namely the skills and confidence necessary to making effective and timely risk-based decisions. Articles: 1. Quality Risk Management: Seeking the Diamonds: Making the Case for Improved Formality in QRM Decision-making https://arrow.tudublin.ie/level3/ 2. Role of Senior Leadership in Quality Risk Management | IVT - Risk - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-management 3. Understanding the Concept of Formality In Quality Risk Management http://www.ivtnetwork.com/article/understanding-concept-formality-quality-risk-management-0 Other Resources: 1. ISO 31010 – Risk Management - https://www.iso.org/iso-31000-risk-management.html 2. ICH Q9. Risk Based Decisions We first encounter it in the Introduction to the guideline: “Effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a company’s ability to deal with potential risks and can beneficially affect the extent and level of direct regulatory oversight.” And specifically, “…some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, both by regulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle.” 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 Harsha Chulki and Stephen Cook. Validation documents are critical to both the internal processes, and external communications, in regulated industries such as pharmaceutical and medical device organizations. Properly recording and managing data is necessary to ensure the integrity and reliability of records. Good Documentation Practices (GDP) lay down the guidelines for preparation, recording, and correction of data as well as the maintenance of the records throughout the lifecycle of a document. Resources for episode: • Compliance Group Webinar Resource: https://www.complianceg.com/webinar • Follow Compliance Group Blogs: https://www.complianceg.com/blog • Annex 5 - WHO | World Health Organization • PQ Forum #10: Technical Writing for Validation • PQ Forum #18. PV Stage 1 Technical Report Format Harsha Chulki is the Head of Global IT, Quality & CSV at ICU Medical. He is a seasoned IT leader with over 15 years of leadership and program management experience building multiple, high performing teams across multiple industries. Chulki is also the Architect of Integrated IT Compliance model with experience installing centralized controls across IT (GxP, SOX, HIPAA, Non-GxP). He can be reached at harsha.chulki@icumed.com Stephen Cook is the VP, QUALITY AND COMPUTER COMPLIANCE at Compliance Group Inc. He has 20+ years of experience in the field of computer systems validation and is an expert on Computer Software Assurance (CSA). He believes that a strong partnership between IT, Quality and the business can lead to creative solutions and that the really good work gets created outside the SOP. He can be reached at stephenc@complianceg.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.

Digitization Of Validation For Effective Off-Site Regulatory “Review” And “Inspection”   This week, Stacey is joined by Ajaz Hussain, Alton Johnson, and Steve Thompson. As agencies like the FDA continue to rely on virtual inspection, we need to take a look at the process, including a review of documents and processes. How can these inspections be more hands-on and eyes-on, allowing for efficient and accurate outcomes? Resources from this episode Article - https://www.ivtnetwork.com/article/digitization-validation-effective-site-regulatory-%E2%80%9Creview%E2%80%9D-and-%E2%80%9Cinspection%E2%80%9D Dr. Ajaz Hussain, Ph.D., Advisory Board Chairman, ValGenesis, Inc. Dr. Hussain is globally recognized for his tireless efforts to improve the predictability of medicinal product development, manufacturing, and associated regulatory processes. As the Deputy Director Office of Pharmaceutical Science, he led some of the U.S. Food and Drug Administration's major initiatives to develop regulatory policies that already have and will continue to have, a significant impact on product development and approval in many geographies. His corporate experience includes leadership of the development and/or regulatory submissions of first-in-class Biosimilar, Follow-on Protein, and Complex Generic products at Sandoz. At Philip Morris International, he took on the challenge of higher levels of uncertainty (regulatory and business) and product complexity to build strategies and systems to successfully move forward development programs on plant-based vaccines, products for tobacco harm reduction, and ensure the credibility of scientific evidence to seek regulatory discussions and submissions. His experience at Wockhardt has helped him to understand the opportunities and talent companies in India have, the challenges they face, and how they can bring forward effective solutions to maintain and enhance competitiveness and credibility. He also has extensive teaching experience, he served as a tenured Associate Professor of Pharmaceutics at the University of Cincinnati, where he established a research program on Computer-Aided Formulation Design. Based on his broad experience in academia, US FDA, and industry he founded his consulting practice Insight Advice & Solutions LLC. Alton Johnson, Ph.D., Alton Johnson Consulting, LLC Alton Johnson is an industry leader and expert in pharmaceutical development, manufacturing, technology, and business solutions. In his current consulting role, he develops strategies and solutions for clients in the areas of new product development, manufacturing, digital transformation, pharmaceutical technology, business development, and compliance. He has 30-plus years of leadership experience at Pfizer across, Technical Services, Innovation, and Advanced Manufacturing Technology / Pharma 4.0. His extensive publications and presentations encompass Quality by Design, Risk Management, Knowledge Management, Validation, Process Analytical Technology, Continuous Processing, and Pharma 4.0, for organizations including ISPE, DIA, PDA, and AAPS. He has served in leadership roles for PhRMA, on the board of Smart Manufacturing Leadership Coalition, and as Chair of the Steering Committee for NIH-sponsored Engineering Research Center. Steven D. Thompson Steve has over 20 years’ 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 that include 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. 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. Willis Thomas to talk about reducing human error in pharmaceutical manufacturing. Efforts to investigate root causes are typically incomplete or poorly performed. Most regulatory authorities no longer accept human error as a justifiable cause of errors, making it necessary, now more than ever, to ensure proper systems are in place, employees are thoroughly trained, procedures are being followed and equipment is not deficient in any way to reduce or prevent human error.   Dr. Thomas has worked for large corporations and academic institutions in the areas of human resources, learning and development, quality assurance, project management, sales and marketing, measurement and evaluation, and operations. He has been in senior management for life sciences companies for the past 15 years. Dr. Thomas, in his current full-time role, is involved in preventing and reducing human error from an HR perspective. He is also adjunct faculty at the Lake Forest Graduate School of Management, International Institute for Learning and Institute of Validation Technology. Dr. Thomas’ publications have received global recognition from associations such as the Project Management Institute (PMI) where he received the Cleland Award for “The Basics of Project Evaluation and Lessons Learned.” This book was an 8-year effort that enhanced the framework for the evaluation of projects using the PMBOK® Guide. He has been a featured speaker on an international basis and has received the Apex Publication Excellence Award for implementing useful tools for project management, evaluation and training, and has been a member of the speaking faculty for IVT since 2005 and responsible for US Human Resources for PQE Group, Inc. In addition, he holds the certified performance technologist certification (CPT) from ispi.org. 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 back 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 episode our Risk Revolution team, Lori Richter and Nuala Calnan once again host their colleagues Ghada and Vivian for a robust conversation around risk curious concept, and expand into the why’s and why not’s and the views of this practice under PICs. The group also reviews the need for training and development around risk, formalization of a risk management process, a top-down approach to building culture, and the need for critical thinking and risk-based decision making.    Links to Risk Revolution Takeaways: The JVT Special edition on QRM - https://www.ivtnetwork.com/journal-validation-technology/journal-of-validation-technology-3693 Role of Senior Leadership in Quality Risk Management - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-management Knowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge... http://www.ivtnetwork.com/article/knowledge-currency-managing-risk-novel-framework-unite-quality-risk-management-and-knowledge Link to the ISPE Cultural Excellence Report - https://ispe.org/news/cultural-excellence-report  PIC/s A Recommended Model for Risk-Based Inspection Planning in the GMP Environment – https://www.picscheme.org/layout/document.php?id=160 PIC/s Assessment of Quality Risk Management Implementation - https://picscheme.org/layout/document.php?id=148 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 PhD at Technological University Dublin.   Nuala Calnan is founder and principal at BioPharm Excel, she holds a PhD in Regulatory Science and 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 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 Masters and PhD level.   Ghada Haddad is an Executive Director at Merck & Company, leading the Global cGMP and Compliance Auditing Organization Prior to this role she was the Head of the Global QRM Center of Excellence at Merck, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree, an MBA and a PhD and has over 22 years of experience, working in the Biotech and Pharmaceutical industries. A board member of PDA, Ghada also chaired the Paradigm Change in Manufacturing (PCMO) initiative which produced a range of technical reports on QRM related topics.   Vivian Rowland is currently an Associate Director, for Quality Systems & Compliance at MSD (also known as Merck & Co.) and prior to joining MSD, Vivian was a GMDP Inspector within the Inspectorate at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for over 10 years. Apart from conducting inspections in the UK and overseas, Vivian was the Technical/Operational Lead for Quality Risk Management (QRM) and a Co-ordinating Committee Member at the PIC/S 2nd Expert Circle on QRM, developing advance training courses on QRM for international inspectors.   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 Wubbolt to help us better understand how to establish criteria around “critical data” and managing it within the data integrity programs of our own business. What is critical data, and why is it important to define it? What are the first steps in establishing the criteria desired to identify critical data? Once we definite critical data, how fully integrate it into our data integrity program? How does “critical” data impact validation? What are some key considerations in critical data collection, and what are the biggest mistakes made here? Given that critical and non-critical data can be stored and maintained in the same database, what special protections of records controls do we need to be mindful of? What are the biggest challenges around critical data, and record controls? Can you highlight a couple of examples where data collection or storage failures have happened? Thinking about critical data reviews in your SOPs, review frequency and risk assessments. What are regulators expectations around critical data during an audit trail review? What are the most common failures or findings during these reviews? 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 once again by Rich Forsyth. Stacey and Rich discuss some strategies for simplifying the cleaning validation activities and achieving efficiencies throughout the process. Richard Forsyth, Principal Consultant Forsyth Pharmaceutical Consulting 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.   Links: FDA Cleaning Validation Guideline from CFR 211.67 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.67 FDA CFR 211 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211 FDA Questions & Answers on Current Good Manufacturing Practices—Equipment - https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practices-equipment EMA Cleaning Guidance - https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf EMA Cleaning Validation Guideline on setting HBELs - https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf QnA on the implementation of the above guideline EMA - https://www.ema.europa.eu/en/documents/other/questions-answers-implementation-risk-based-prevention-cross-contamination-production-guideline_en.pdf ISPE Cleaning Validation Guide - https://ispe.org/publications/guidance-documents/guide-cleaning-validation-lifecycle-applications-methods-controls WHO Cleaning Guidance - https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS20_849_Rev.1_points_to_consider_hbels_in_cleaning_validation.pdf?ua=1 Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

This week, Stacey is joined by Bernard Hsu and Paul Pluta. Stacey and her guests talk about, Food safety and contamination is a concern in the manufacturing plant and in the home. Contamination in the plant due to substandard food handling may ultimately contaminate manufactured product and may sicken employees. Food safety must not be taken lightly; US CDC estimates foodborne illnesses annually sicken 48 million people, hospitalize 128,000 people, and kill 3,000 people – testament to general lack of knowledge or carelessness regarding safe food practices. Bernard Hsu, PharmD , Associate Director, Novartis Oncology Bernard has a decade of experience in pharmaceutical product development at major pharmaceutical companies spanning all phases of development. Earlier in his career, his clinical training was in emergency medicine and toxicology. He is now Associate Director in Oncology Medical at Novartis. Most of Bernard's work today is in medical and scientific communications, both within the industry, and to the general public. Paul Pluta, Ph.D., Editor-in-Chief, IVT Journals Paul has extensive pharmaceutical industry and university academic teaching experience, with many years managing validation in industry. He has written chapters and edited books on cleaning validation. More than 100 publications and presentations all told. Pail has been involved with the Journal of Validation Technology and Journal of GXP Compliance as a writer and editor-in-chief for more than 10 years. Resources from this episode Peer-Reviewed Articles: • Compliance Case Study #16: Microbial Contamination From Foods • CQV #9: What, How, and Why of Handwashing Bernard’s Videos: • A Student Ate 5 Day Old Pasta For Lunch. This Is How His Liver Shut Down. • A Mom Ate 5 Day Old Sushi 🍣 For Dinner. This Is What Happened To Her Brain. • A Toddler Played With His Cat. This Is What Happened To His Brain. • A Student Ate Leftover Potato Salad For Lunch. This Is What Happened To Her Liver. • A Grandma Ate Cookie Dough For Lunch Every Week. This Is What Happened To Her Bones. • A Man Was Licked By His Dog. This Is How His Organs Shut Down. • A Student Ate Gas Station Sushi For Breakfast. This Is What Happened To His Stomach. 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 Alan Golden. On this episode Stacey and Alan talk about ways in which medical device companies can prepare for audits, know what to expect during the audit, and how they should respond to audit findings. Alan Golden, MS, Principal Design Quality Consultants, LLC 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. Links: CFR 21 - Part 806.10. - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=806.10 CFR 21 – Part 806.20 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=806.20 ISO 13485:2016 - Medical device - QMS- Requirements for regulatory purposes - https://www.iso.org/standard/59752.html 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.   On this episode our Risk Revolution team, Lori Richter and Nuala Calnan invite their colleagues Ghada and Vivian to help define Risk Culture, discuss everyone’s role in achieving a culture that embraces and learns from risk, highlighting a need for risk identification, covering some risk communication tools, and broadening the understanding around risk-based decision-making processes. Ghada provides some valuable insights into risk excellence from her experience as a team leader on the Global QRM Center of Excellence at Merck, while Vivian provides a needed regulatory framework from here time as an agent at MHRA.   Links to Risk Revolution Takeaways: The JVT Special edition on QRM - https://www.ivtnetwork.com/journal-validation-technology/journal-of-validation-technology-3693 Role of Senior Leadership in Quality Risk Management - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-management Knowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge... http://www.ivtnetwork.com/article/knowledge-currency-managing-risk-novel-framework-unite-quality-risk-management-and-knowledge Link to the ISPE Cultural Excellence Report - https://ispe.org/news/cultural-excellence-report  PIC/s A Recommended Model for Risk-Based Inspection Planning in the GMP Environment – https://www.picscheme.org/layout/document.php?id=160 PIC/s Assessment of Quality Risk Management Implementation - https://picscheme.org/layout/document.php?id=148 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 PhD at Technological University Dublin.   Nuala Calnan is founder and principal at BioPharm Excel, she holds a PhD in Regulatory Science and 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 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 Masters and PhD level.   Ghada Haddad is an Executive Director at Merck & Company, leading the Global cGMP and Compliance Auditing Organization Prior to this role she was the Head of the Global QRM Center of Excellence at Merck, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree, an MBA and a PhD and has over 22 years of experience, working in the Biotech and Pharmaceutical industries. A board member of PDA, Ghada also chaired the Paradigm Change in Manufacturing (PCMO) initiative which produced a range of technical reports on QRM related topics.   Vivian Rowland is currently an Associate Director, for Quality Systems & Compliance at MSD (also known as Merck & Co.) and prior to joining MSD, Vivian was a GMDP Inspector within the Inspectorate at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for over 10 years. Apart from conducting inspections in the UK and overseas, Vivian was the Technical/Operational Lead for Quality Risk Management (QRM) and a Co-ordinating Committee Member at the PIC/S 2nd Expert Circle on QRM, developing advance training courses on QRM for international inspectors.   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 Dr. Tim Sandle. On this episode Stacey will speak with Dr. Tim Sandle about the potential risks to cleanrooms and laboratories posed by some of today’s fads. Links: Microbial Contamination Concerns Linked With E-Cigarettes And Vaping Products: https://www.ivtnetwork.com/article/microbial-contamination-concerns-linked-e-cigarettes-and-vaping-products Alternative Risks To Cleanrooms Presented By People: Tattoos, Piercings, Sunbeds: http://www.ivtnetwork.com/article/alternative-risks-cleanrooms-presented-people-tattoos-piercings-sunbeds FDA (2019) Think Before You Ink: Are Tattoos Safe?: https://www.fda.gov/consumers/consumer-updates/think-you-ink-are-tattoos-safe 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 a number of advisory committees and standards boards. Dr. Sandle has written or edited over 25 books, more than 100 book chapters, over 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.

This week, Stacey is joined by Emma Ramnarine to continue their series discussing One-Voice-of-Quality. This discussion focuses in on the details for a greater understanding around the how’s and who’s that are necessary to this One-Voice-of-Quality vision. Emma has over 15 years of experience in the pharmaceutical, biotechnology and medical device industry in the area of Quality System with focus on developing and leading Quality Risk Management (QRM), validation, and change control. She is a worldwide-recognized expert on QRM, providing QRM leadership, governance, guidance, and training to regulatory authorities and at industry forums. Emma has been an active member of the Parenteral Drug Association (PDA) for 13 years. She most recently led PDA”s Task Force for Technical Report No. 68 on “Risk Based Approach for Prevention and Management of Drug Shortages” and is also a member for PDA on the inter-association European Drug Shortages Team that was formed under EMA”s direction. She also led the Task Forces for PCMOSM Technical Report Series No. 54 on “Implementation of Quality Risk Management”. Emma joined the PDA Board of Directors as of Jan 2015, has been on PDA”s Regulatory Affairs and Quality Advisory Board (RAQAB) since 2013, and also co-leads PDA”s QRM Interest Group. Emma holds an M.S. in Pharmaceutical Sciences from University of Connecticut, an M.S. in Medicinal & Pharmaceutical Chemistry, and a B.S. in Pharmacy, both from University of Indore, India. Read more from Emma on this topic: 1. Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based Approaches 2. Industry One-Voice-of Quality Concept Paper: Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transforms Post-Approval Change Management 3. Continual Improvement While Maintaining A State of Control: A Concealed Paradox or a Mutual Interdependence? 4. Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction. 5. PDA PAC iAM 2017 Survey on Post-Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry 6. PDA Technical Report 68: Risk-Based Approach for Prevention and Management of Drug Shortages Website link to discussion topic: https://prst.ie/1vq 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 Validation Week awards ceremony. You'll find who won this years awards and what those recipients did to achieve their awards.   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 Rich Forsyth, Forsyth Pharmaceutical Consulting. Stacey and Rich discuss the lifecycle approach to cleaning validation, and the importance of creating cGMP approved cleaning programs that encompass the applications, methods and controls necessary for creation and launch of compliant cleaning programs that meet or exceed regulatory expectations.   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. Links: FDA Cleaning Validation Guideline from CFR 211.67 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.67   FDA CFR 211 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfmCFRPart=211   FDA Questions & Answers on Current Good Manufacturing Practices—Equipment - https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practices-equipment EMA Cleaning Guidance - https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf EMA Cleaning Validation Guideline on setting HBELs - https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf QnA on the implementation of the above guideline EMA - https://www.ema.europa.eu/en/documents/other/questions- answers-implementation-risk-based-prevention-cross-contamination-production-guideline_en.pdf   ISPE Cleaning Validation Guide - https://ispe.org/publications/guidance-documents/guide-cleaning-validation-lifecycle- applications-methods-controls   WHO Cleaning Guidance - https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS20_849_Rev.1_points_to_consider_hbels_ in_cleaning_validation.pdf?ua=1   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

This week, Stacey is joined by Eric Kastango and Kevin Hansen to talk about compounding and specialty pharmacy, regulations, innovations and reputations. Compounding Pharmacists have a very challenging, and rewarding job, in their development of specialized medicines for individualized patient care. For many, there is satisfaction in working to solve the needs of patients through innovative partnership with the patient and their practitioner. Too often professionals in this space are mired by regulatory inconsistencies, special interest groups, lack of transparency and a tarnished reputation, all of which make this highly challenging job even more difficult. Today we will talk about some of the hurdles and opportunities in Compounding.   Eric Kastango, Expert Consultant and Pharmacist Eric has dedicated his life's work to patient safety through better sterile compounding, aseptic manufacturing, lean production, and robust quality management practices. He has practiced pharmacy in hospital, community, and homecare settings in a variety of roles. He was previously Corporate Vice President of Pharmacy Services for Coram Healthcare and also managed a cGMP outsource manufacturing operation for Baxter Healthcare. In addition to his consulting role, Eric continues to serve as a sterile compounding, 503B outsourcing, and patient safety subject matter expert for his clients, the American Society of Health-System Pharmacists, State Boards of Pharmacy, and was one of the key US Department of Justice expert witnesses during the New England Compounding Center trials from 2017-2019.   Kevin Hansen, PharmD, Assistant Director of Pharmacy Moses H. Cone Memorial Hospital Dr. Kevin Hansen is Assistant Director of Pharmacy at Moses H. Cone Memorial Hospital in Greensboro, North Carolina and provides leadership and operational oversite for pharmaceutical compounding and pharmacy perioperative services. He is a preceptor for the Health-System Pharmacy Administration residency program. In addition, Dr. Hansen serves as adjunct faculty for The University of North Carolina Eshelman School of Pharmacy. Within the Moses H. Cone Memorial Hospital, as part of the Cone Health system, Dr. Hansen is involved in several committees and initiatives related to his practice interests of pharmaceutical compounding, handling hazardous drugs, medication and compounding safety, drug shortage management, and pharmacy perioperative services. He is a member of ASHP and the North Carolina Association of Pharmacists (NCAP). He currently serves a leading role through ASHP’s Sterile Products Workgroup, as part of the Section of Pharmacy Practice Managers (SPPM).   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

On this edition of the QRM Series Stacey, Lori, and Nuala are joined by Chris Flask. The team are going to take a look at risk management in the broader context and get some facts straight!   De-risking your supply chain: http://www.ivtnetwork.com/sites/default/files/NUALA-IVT%20Network%20-%20De-risking%20Your%20Supply%20Chain.pdf   Risk Assessment Steps for Success: http://www.ivtnetwork.com/sites/default/files/NUALA-Risk Assessment Steps for Success_PRST@TUDublin and BioPharmChem Ireland.pdf   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. Ross Caputo, President Eagle Analytical. Stacey and Dr. Caputo discuss contamination control. Contamination control is very important for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms. Any contamination that does occur must be thoroughly investigated, which often is time consuming, causing potential delays in production, and this is true for compounding pharmacies of all types. Dr. Caputo has over 30 years of experience in the FDA-regulated pharmaceutical industry on sterilization research and aseptic processing focusing on process optimization and control. He has authored more than 50 publications and owns 15 patents, all related to infection control, sterilization processes and the production of sterile product. Throughout his career, Dr. Caputo has been an active participant and committee member of organizations such as AAMI/ISO and PDA, which are charged with the development of standards for the regulated marketplace. He has a PhD in Microbiological Physiology and Immunology from Miami 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 is joined by Dr. Kevin Hansen, PharmD Assistant Director of Pharmacy. Stacey and Dr. Hansen discuss how innovations in the RTA space are changing the way some hospital systems and their compounding pharmacies source these forms of drugs. Dr. Hansen is Assistant Director of Pharmacy at Moses H. Cone Memorial Hospital in Greensboro, North Carolina and provides leadership and operational oversite for pharmaceutical compounding and pharmacy perioperative services. He is a preceptor for the Health-System Pharmacy Administration residency program. In addition, Dr. Hansen serves as adjunct faculty for The University of North Carolina Eshelman School of Pharmacy. Within the Moses H. Cone Memorial Hospital, as part of the Cone Health system, Dr. Hansen is involved in several committees and initiatives related to his practice interests of pharmaceutical compounding, handling hazardous drugs, medication and compounding safety, drug shortage management, and pharmacy perioperative services. He is a member of ASHP and the North Carolina Association of Pharmacists (NCAP). He currently serves a leading role through ASHP’s Sterile Products Workgroup, as part of the Section of Pharmacy Practice Managers (SPPM). 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.