Voices In Validation

This week, Stacey and Nuala sit down with Jayet Moon, author of "Foundations in Quality Risk Management" to review some of the key discussion points from his book and share his views on how risk management “is central to the science of prediction and decision-making;” and how “holistic and scientific risk management creates resilient organizations, which survive and thrive by being adaptable.” Jayet will also explain how lobsters can live forever.

Resources from this episode:

1. A Quantitative Method for Modelling

About our guest:

Jayet Moon 

Jayet has earned a master’s degree in biomedical engineering from Drexel University in Philadelphia and is a Project Management Institute (PMI) Certified Risk Management Professional (PMI-RMP). Jayet is also a Chartered Quality Professional in the UK certified by the Chartered Quality Institute (CQI). He is also an Enterprise Risk Management Certified Professional (ERMCP) and a Risk Management Society (RIMS) certified Risk Management Professional (RIMS-CRMP). Jayet was recently awarded the Australian Organization for Quality 'Passion for Excellence' Award and recognized as American Society for Quality '40 under 40' Rising Star in their November 2021 issue of Quality Progress magazine. He is a Fellow of Royal Society for Arts (FRSA) and a Fellow of International Institute for Safety and Risk Management (FIIRSM). He is the author of the book, ‘Foundations of Quality Risk Management’ published by ASQ Quality Press, and holds ASQ CQE, CQSP, and CQIA certifications. Popular articles authored by him on Quality and Risk Management have been published in global trade magazines such as Quality Press (USA), Quality World (UK), Quality Business (Australia and New Zealand), QCI Magazine (India), and eQuality Edge (South Africa).

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

This week, Stacey is joined by Kate Coleman to discuss the essentials for building a culture of quality while achieving customer satisfaction. Across life sciences, teams concur that quality, defined by safe, effective, and compliant products, is a prerequisite of the pharmaceutical, biomedical or medical device industry.  The Quality Management System then provides the basic infrastructure needed for defining and validating the documents, processes, procedures, and systems to meet the company's quality objectives. The bi-product?  ̶  the highest customer and patient satisfaction.

Resources from this episode:

Overview of the Quality System Regulation - US Food and Drug

Guidance for Industry Q10 Pharmaceutical Quality System

Can a robust QMS help you achieve customer satisfaction?

About Our Guest:

Kate Coleman, Senior Director/ Principal Consultant at PharmaLex

Kate has worked in Quality roles in the Pharma Industry up to management level for 19 years, covering several platforms including Biologics, Sterile Fill Finish, Vaccines, and Oral Dose. Kate is a practicing QP, Principal Consultant, a qualified Lead Auditor, and an SME in Risk Management, New Facility Design/Start-Up, QC, and Sterility Assurance.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

This week, Stacey is joined by Amanda Coogan to discuss the opportunities and challenges of implementing automated clinical trial management solutions using RBM. Given our current environment, it is no surprise that pharma and device companies are doing everything possible to boost efficiencies. Increasing drug development and production in safe and effective ways, while limiting resources used and dollars spent can be a balancing act. This also applies to clinical trials. Adoption of a risk-based monitoring (RBM) approach may be the best method to support clinical studies while keeping an eye on compliance.

Resources from this episode:

Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring - Guidance for Industry (2013)

A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers - Draft Guidance for Industry (2019)

Tackling the Challenges of Transitioning to Risk-Based Monitoring

About Our Guest:

Amanda Coogan, Senior Customer Partnership Manager, Remarque Systems Amanda spent the first 12 years of her clinical research career in clinical operations for university hospitals and medical device firms supporting domestic and international studies. She then transitioned to the software industry, where she has served for 6 years as a consultant, subject matter expert, and project manager to small and large pharma, medical device, and CRO customers supporting their implementation of Risk-Based Quality Management. In addition to working with customers to optimize their use of technology within their RBQM strategy, she provides clinical trial operation expertise to support software product development. She can be reached at [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 by Bryan Prince to talk about the implementation of the 2019 final version of USP 800, and how it is not currently being enforced by most states but quite a few pharmacies around the country are either in the planning and budgeting phase or have already moved forward with construction and being compliant with USP 800 standards.

Resources from this episode:

USP General Chapter Hazardous Drugs regulations

Physical Environment Provisions of USP

About our guest:

Bryan Prince is the owner and lead consultant at Lab Red Pharmacy Consultants.  His early career consisted of more than a decade in construction before moving to engineered containment serving the pharmaceutical industry and now the compounding industry.  Since 2015 Bryan has designed and consulted on more than a hundred compounding pharmacies working with owners, architects, engineers, and contractors. 

Email:  [email protected]  and watch videos http://compoundingworkflow.com

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

This week, Stacey is joined by Nuala Calnan and Valerie Mulholland for an Ask Me Anything session on Quality Risk Management. Valerie answers questions about ICH Q9, ISO Divergence, ICH Q12, Analytical Lifecycle Management, Quality Management Maturity, and much more.

Welcome to Risk Revolution, a monthly series of the Voices in Validation podcast, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.

Resources from this episode:

QRM: a Case for Convergence

Risk-Based Decision Making: PODCAST RECORDING

Risk Management, Knowledge Management, and the Risk

Understanding the Concept of Formality In Quality Risk

Quality Management Maturity – A Pilot Program of the FDA

ICH Q9 R1 concept document

ICH Q14 Concept Paper

2021 Updated PIC/s Aide-Memoire on Assessment of QRM Implementation

Sept 24, 2021, Pre-post version of USP 1220 Chapter on Analytical Procedure Life Cycle

About Our Guest: Valerie Mulholland Valerie Mulholland is the CEO of GMP Services Ltd and is a GMP/Quality Consultant in Europe. She is a practitioner in the area of Quality Risk Management and is researching the topic of Risk-Based Decision Making for a Ph.D. dissertation with the Pharmaceutical Regulatory Science Team in TU Dublin.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

This week, Stacey and industry expert, Chris Wubbolt, count down the top five data integrity issues when complying with GMP guidance. Data Integrity is a critical element to GMP compliance, and all life science manufacturers need to develop and maintain processes for managing their data, reducing the risk to the integrity of that data, and stored properly. Of course, this is all part of the Regulatory Guidelines which have been in place for years. Still, nearly half of all warning letters contain data integrity components.

Resources for this Episode:

Data Integrity and Compliance with cGMP Guidance

Guideline on data integrity - WHO | World Health Organization

Part 11, Electronic Records; Electronic Signatures - Scope and Application

About Our Guest:

Chris Wubbolt, Principal, QACV Consulting

Chris has over 25 years of experience in the regulated industry and has provided compliance, quality assurance, and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

This week, Stacey welcomes back Siegfried Schmitt to the show. Stacey and Siegfried discuss the complexities in supply chain management, the expectations for a GDP audit, and deficiencies in distribution processes. Maintaining product safety and quality during distribution is of utmost importance in the pharmaceutical industry. Just like in other areas of drug manufacture, there is an expected dedication to quality and compliance, which should be present in every aspect of distribution. It is the responsibility of the drug company to comply with distribution requirements including storage and transport of their products, ensuring its safety and security throughout the supply chain.

About Our Guest:

Siegfried Schmitt

Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems, including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity, and Supply Chain, as well as a trusted expert for regulatory, compliance, and industry-best-practices projects. Siegfried has more than 30 years of experience in the healthcare industry, spanning manufacture, analytics, validation, and quality assurance. He received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland, and is a Fellow of the Royal Society of Chemistry.

For more information or to register for the Compounding Pharmacy Compliance East conference, please visit: https://bit.ly/3yzhlnN

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

This week, Stacey is joined by Ken Shitamoto to explore critical thinking in the systems validation department and share concepts and case history. Most industry folks have heard about CSA and understand the basics behind the shift in priorities. What’s better left to understand is the if’s and how’s around adoption and implementation within our own organizations. A risk-based approach is nothing new. However, the evolution centers on a risk-based approach using critical thinking, with a focus on assurance needs, testing activities for our higher-risk activities.

Ken Shitamoto, MS

Senor Director, IT, Gilead Sciences

Ken leads the IT quality engineering function at Gilead Sciences, which performs software quality assurance (testing), validation, and infrastructure qualification. He is a multi-disciplined professional with extensive experience in quality engineering, quality management, project management, and software development. He has been in the biopharmaceutical space since 1993 and has worked both on the manufacturer, vendor, and consulting sides of the business. Additionally, he has also performed over 100 GXP computer systems compliance audits globally. He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively. He is an avid supporter of the American Lung Association, and Ken and his daughter have raised over 130K dollars to fight lung disease.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

This week, Stacey is joined by Renee Phillips to discuss the pros and cons of transitioning to a continuous manufacturing system. Batch production is time-consuming yet remains a popular and time-tested method used in the pharma industry today - but some industry leaders, along with the FDA, have taken steps toward or are now contemplating a shift to continuous manufacturing. This means all stages of drug production run through to the final product, without a stop during its production, thus shut down of equipment between “batches” is required, which eliminates downtime.  CM  saves time and reduces the likelihood of human error, but is it realistic at this point in time?

Resources for this episode:

FDA issued draft guidance, Quality Considerations for Continuous Manufacturing

Rogers, Luke & Jensen, Klavs F. (2019). Continuous manufacturing – the Green Chemistry promise?. The Royal Society of Chemistry. Green Chem., Volume 21, 3481-3498.

Moore, Christine M. V., Garcia, Thomas P., Hausner, Douglas B., Ben-Anat, Inna. (2019) Holistic Control Strategies for Continuous Manufacturing. Pharmaceutical Engineering, May/June 2019

Srai, Jagjit Singh., Settani, Ettore., Aulakh, Parminder Kaur., Evaluating the Business Case for Continuous Manufacturing of Pharmaceuticals: A Supply Network Perspective. Continuous Pharmaceutical Processing, June 2020, 477-512

Van Arnum, Patricia. Pharma Industry Weighs in on Continuous Manufacturing. June 19, 2019

Manning, Richard., Sciacca, Rich., Continuous Manufacturing in Pharmaceuticals: Economic and Policy Issues. Bates White Economic Consulting, October 2018

About Our Guest:

Renée L. Phillips is an Associate Director of Global Regulatory Affairs at Janssen Research &  Development,  LLC,  a  pharmaceutical company of  Johnson  &  Johnson.  Renée has responsibility for Chemistry Manufacturing & Controls for API’s and marketed products. Previously she has held positions in Regulatory Affairs at Johnson & Johnson Consumer Companies,  Wyeth  Consumer  Products,  a  small start-up pharma company, and an environmental chemistry laboratory.  Renée currently serves as an adjunct professor at Temple University School of Pharmacy where she teaches courses in good manufacturing practices and global drug registration requirements. She earned her Bachelor of Science in Biochemistry from Georgian Court College and a Master of Science in Regulatory Affairs from San Diego State University.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

This week, Stacey and Nuala invite a regular IVT contributor and industry disruptor Karen Ginsbury to innovate and revolutionize the future of quality management within the pharmaceutical and biopharmaceutical, and med device sectors. Karen will share her views on ICH Q10 and what must happen next.

Resources from this episode:

One Voice of Quality Website

One-Voice-of-Quality (1VQ) Solutions Part 2 - Podcast Episode | IVT

One-Voice-of-Quality (1VQ) Solutions – an Enhanced Science and ...

Elon Musk Hiring Ad

What Is Industry 4.0?

About Our Guest: Karen Ginsbury Karen is a pharmaceutical consultant who brings hands-on experience in designing and implementing environmental control programs within multinational pharmaceutical companies. She started her career in the industry by taking EM samples on the factory floor and brings her own unique perspective to her lively and instructive presentations. Ms. Ginsbury has over twenty years of industry-based experience in quality assurance and compliance and has published a book on compliance auditing for pharmaceutical manufacturers. Ms. Ginsbury is a past holder of IVT’s Presentation of the Year and Web Seminar Presenter of the Year and regularly lectures around the world on pharmaceutical topics.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.