Voices In Validation

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 [email protected]

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 [email protected].

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

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

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

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 [email protected].

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

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.