Voices In Validation
Risk Revolution part 2

Risk Revolution part 2

January 19, 2021

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:

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.

Identification and Management of Critical Data

Identification and Management of Critical Data

January 12, 2021

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.

Grouping Products & Equipment for Cleaning Validation & Selection of Worst-Case Parameters

Grouping Products & Equipment for Cleaning Validation & Selection of Worst-Case Parameters

January 5, 2021

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.

You Are What You Eat: Food Contaminants and Food Safety in the Manufacturing Facility and Home

You Are What You Eat: Food Contaminants and Food Safety in the Manufacturing Facility and Home

December 29, 2020

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.

Effective Audits in the Medical Device Industry

Effective Audits in the Medical Device Industry

December 22, 2020

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.

Risk Revolution part 1

Risk Revolution part 1

December 15, 2020

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:

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.

Microbiological Risks Associated With Pop-Culture Trends

Microbiological Risks Associated With Pop-Culture Trends

December 8, 2020

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.

1VQ Solutions: an Enhanced Science and Risk-Based Approach to Post-Approval Changes – Part 2

1VQ Solutions: an Enhanced Science and Risk-Based Approach to Post-Approval Changes – Part 2

December 1, 2020

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.

Validation Week Awards

Validation Week Awards

November 24, 2020

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.

A Life Cycle Approach to Cleaning

A Life Cycle Approach to Cleaning

November 17, 2020

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.

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