Voices In Validation

In this episode, we will hear an exclusive conversation from the recent CSV Virtual Event, "Excellence and Next-Generation Approaches to Quality System Monitoring." This discussion was moderated by Michelle Miller and features Nuala Calnan, Alyce Deegan, and Daniel Caparros.

The discussion will be focused on providing reflections on the current landscape, team challenges in data governance programs and policies, understanding sources of bad data, missing data, data consistency and data integrity, as well as the speed of data delivery and defining metrics, and help in establishing digitally-enabled facilities using real-time analytics for agility in meeting ever-changing markets, and leveraging predictive capabilities to ensure highest levels of quality and control.

About the panel:

Michelle Miller

Michelle Miller is Director of Global Validation at Illumina Inc. In this role, Michelle leads the global non-product validation across the company. This includes the strategy and execution of validation for facilities, manufacturing processes, consumables production, quality system, enterprise software, and other systems across all of Illumina. Over the past 12+ years, she has held roles in product engineering, product transfer, validation engineering, and quality assurance, supporting the manufacturing of microarrays, genome sequencing reagents, and consumables.

Nuala Calnan

Nuala is a 25 year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) on patient safety and product quality.

Nuala works with organizations to transform organizational culture, deliver more effective end-to-end risk management, implement knowledge excellence strategies, behavior-based good data governance, and enhance performance management through people.

Nuala co-leads the ISPE Quality Culture Team, is a founding member of the ISPE Knowledge Management Task Team, and an Arnold F. Graves Scholar at TU Dublin, Ireland, where she leads many patient-focused regulatory science research projects at Masters and Ph.D. level.

Alyce Deegan

Alyce has over 20 years of experience in the Pharmaceutical, Medical Device, and Gene Therapy industries. Alyce recently was the CSV Director at SeaGen and the IT Director of Manufacturing and GxP Lab Systems at Juno Therapeutics a CAR-T Cell Therapy Manufacturing Plant located in Bothell, WA. Throughout Alyce’s career, she has held leadership positions in Quality, Validation, and IT at Pfizer, Biogen, and ThermoFisher.

Daniel Caparros

This week, Stacey is joined by FDA members Jennifer Maguire, Nandini Rakala, Alex Viehmann, Carla Lundi, and Lyle Canida. Stacey and the team from the FDA discuss the FDA announced innovative Quality Management Maturity Pilot Programs for Manufacturers of Drug Products and Active Pharmaceutical Ingredients. Results of this pilot program are intended to aid in the creation of a future rating system for drug makers, ranking the maturity of their quality management systems. Such a rating system and associated incentives for mature rating could lead to a renewed effort in risk management and provide motivation for companies to invest in their QRMs and the resources surrounding them.

Resources from this episode:

Pharmaceutical Quality for the 21st-century report

Quality Management Maturity Pilot Program as announced by the FDA

About Our Guests:

CDR Lyle Canida is a PHS officer with 11 years at FDA. He has a Pharm.D., M.S. in Pharmacoepidemiology, and is Certified in Public Health. During his time with FDA, he has worked in various roles including IND and NDA reviews for clinical pharmacology genomics and overseeing post-market safety programs for drugs, foods, cosmetics, and dietary supplements. More recently, he has been with the Office of Pharmaceutical Quality helping to drive quality surveillance programs and other strategic initiatives.

Dr. Jennifer Maguire is the Deputy Director of the Office of Quality Surveillance/OPQ/CDER/FDA. The office assesses intelligence throughout the product lifecycle to inform stakeholders about the state of pharmaceutical quality and uses data analytics to drive surveillance decisions. During her tenure at the agency, Dr. Maguire has contributed to multiple initiatives aimed at modernizing the regulation of pharmaceutical manufacturing and product quality including QbR, QbD, ICH Q12, Site Selection Model, Quality Metrics, and Quality Management Maturity. Dr. Maguire has a BS in Chemical Engineering from the University of Virginia and a Ph.D. in Industrial and Physical Pharmacy from Purdue University.

Dr. Nandini Rakala is a Data Scientist and Mathematician by background, currently working as a Visiting Associate within the Center for Drug Evaluation and Research at the U.S. FDA. Dr. Rakala earned her Ph.D. in Operations Research in May 2020, from the Department of Mathematical Sciences at Florida Tech, with her primary research work in Optimization and Machine Learning. She also holds a master’s degree in Applied Mathematics and Computing from Manipal University, India; and a bachelor’s degree in Mathematics Honors from the Sri Sathya Sai Institute of Higher Learning, India. During her past 2.5 years with the FDA, Dr. Rakala has worked on multidisciplinary regulatory research projects, employing her expertise in operations research, machine learning, natural language processing, programming skills, and knowledge of efficient quality management practices regarding pharmaceutical manufacturing. She is currently leading and/or serving as a subject matter expert on critical OPQ pilot programs such as the Quality Management Maturity, Quality Metrics, predictive modeling of PQS-CAPA effectiveness, prioritization of Field Alert Reports, drug shortage analysis, Report on the State of Pharmaceutical Quality, quality signal detection and topic modeling of post-market surveillance data. Dr. Rakala has had an opportunity to present her research work on several occasions at various conference seminars, and she is a recipient of numerous prestigious awards. In her personal free time, Nandini enjoys volunteering in community service activities, serving as a judge, playing tennis, writing, reading articles, and biographies.

Alex Viehmann is currently the Director for the Division of Quality Intelligence II within the Office of Pharmaceutical Quality/Office of Quality Surveillance.  The Division performs post-market quality-based assessments of drug sites and products, enhanced by data integration and analytics tools developed in support of monitoring and improving drug quality, to inform congressional inquiries and data calls, future GMP inspections, enforcement decisions, and application assessment.  Alex joined the FDA in May 2008 as an Operations Research Analyst in the Policy and Standards Development staff within the Office of Pharmaceutical Sciences where he collaborated with stakeholders on developing policy and standards on sampling, test method evaluation, and statistical quality control.  He then transitioned to the Science and Research staff where he provided statistical support for CMC review, GMP inspections, and enforcement actions.  Since joining OQS in 2015, Alex has guided the development of OPQ’s Quality Metrics program, CDER/ORA’s New Inspection Protocol Project (NIPP), and OQS’s analytics and modeling program.  He is also actively engaged in implementing Pharmaceutical Quality System (PQS) assessments in support of Established Conditions and the Site Engagement Program (SEP).  He currently serves as the Regulatory Chair for ICH Q9 and as a member of the PIC/S Expert Circle Working Group on Quality Risk Management. Alex received his bachelor’s degree in economics from the University of Maryland at College Park. 

Carla J. Lundi has been with the FDA as a Consumer Safety Officer since 2002, working initially with the Office of Regulatory Affairs in the Los Angeles District. While with ORA she was a Drug Specialist, member of the Pharmaceutical Inspectorate, and member of the Drug Foreign Inspection Cadre specializing in sterile drug manufacturing inspections. In 2016 she transferred to CDER’s Office of Pharmaceutical Quality, Office of Quality Surveillance working primarily on monitoring drug product and manufacturing site quality-related signals for mitigation of urgent quality issues; evaluation and reporting of data related to pharmaceutical quality and drug availability for internal and external customers; collaborating with business partners to determine data to be collected from sites through onsite inspections or other innovative approaches; and drug training collaboration and development.

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

This week, Stacey welcomes back Nuala Calnan and Lori Richter for another episode in the Risk Revolution series. In this episode, we discuss the importance of facilitation in the risk management process and how it leads to the success of a risk assessment. Joining in on this conversation is Tiff Baker, Senior Consultant from ValSource.

Resources in this episode:

Humble Inquiry - The Gentle Art of Asking Instead of Telling Building Positive Relationships and Better Organizations, (2021) Edgar Schein

The Surprising Power of Questions HBR

Bias, Heuristics & Risk (Pt. 1) on Risk Revolution | IVT

Bias, Heuristics & Risk (Pt. 2) on Risk Revolution | IVT

About Our Speakers

Lori Richter

Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx, she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada, and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a Ph.D. at Technological University Dublin.

Nuala Calnan – 

Nuala is a 25-year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end risk management, implementing knowledge excellence strategies, behavior-based good data governance and enhancing performance management through people. Nuala co-leads the ISPE Quality Culture Team and is a founding member of the ISPE/PQLI Task Team on Knowledge Management. She is also the Arnold F. Graves Scholar with the  Pharmaceutical Regulatory Science Team at TU Dublin, Ireland, where she leads a number of patient-focused regulatory science research projects at the Masters and Ph.D. levels.

Tiff Baker – 

Tiff Baker, is a Senior Consultant at Valsource.  Tiff has been working full time in the QRM space for over ten years, and in micro roles within the industry prior to that.  She has implemented QRM programs for companies internationally, delivered risk training to industry and regulators alike, developed custom risk tools to meet client needs, and facilitated many risk assessments over the years.  She is a co-lead for the Parenteral Drug Association’s Remote Audits and Inspections Task Force as well as an instructor for the PDA Training and Research Institute.  In addition, Tiff contributed as an author to ISPE’s Baseline Guide 5 for Commissioning and Qualification to incorporate risk as well as several Points to Consider documents for the PDA.

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

This week, Stacey is joined by Paul Pluta and Karen Zimm to discuss the particulars of the drug naming process, definitions, and categories for drug names. Karen and Paul present case study scenarios where drug name communications have led to adverse events. 

A drug may be known by different names during its development and commercial lifecycle. Medication safety problems associated with drug names have long been recognized as a significant problem by healthcare professionals. Whether it’s look alike or sound alike errors, drug modifier misidentification, or proprietary vs. non-proprietary names, confusion may lead to medication errors – which of course can have fatal effects on patients and consumers.

Articles:

1. Medication Safety: Industry Considerations Part 1 - Problem Overview https://www.ivtnetwork.com/article/medication-safety-industry-considerations-part-1-problem-overview 

References:

1. FDA.  Guidance for Industry.  Best Practices in Developing Proprietary Names for Drugs. https://www.fda.gov/media/88496/download 

Karen is currently an Associate Director in Global Regulatory Affairs for Johnson & Johnson Pharmaceutical Research and Development with responsibility for Chemistry Manufacturing & Controls for API’s and marketed products. Previously she has held positions in technical operations with Pharmaceutical Sourcing Group – Americas, a division of Ortho-McNeil Pharmaceutical and research & development for the R.W. Johnson Pharmaceutical Research Institute and Whitehall Robins Healthcare (Wyeth Consumer Products). She earned her Bachelor of Science in Pharmacy and PhD in Pharmaceutics under Dr Joseph Schwartz from the Philadelphia College of Pharmacy and Science, MBA in Pharmaceutical Management from Drexel University, and the MS in Quality Assurance/Regulatory Affairs from Temple University. In addition she is a licensed pharmacist and an adjunct professor for the School of Pharmacy/Quality Assurance-Regulatory Affairs at Temple University in Philadelphia, PA.

Paul is a pharmaceutical scientist with technical development, manufacturing, and management experience. He has been involved in nearly all phases of pharmaceutical development and manufacturing including R&D formulation and process development, dissolution, stability, regulatory, quality assurance/control, compliance, specifications, scale-up, technology transfer, technical support, and validation/qualification. In his time at Abbott he had numerous new product and supporting regulatory submissions, as well as, extensive product technical support experience. Additionally, his validation experience includes manufacturing process validation, cleaning validation, and associated systems qualification including aseptic systems. He was also a practicing pharmacist for many years in community and hospital environments with direct involvement in preventing medication errors. He may be reached at [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 Roberta Goode, who will moderate a discussion on Combination Product Development and some of the challenges that arise in the process. Stacey and Roberta are joined by panelists Becky Leibowitz from Janssen, Kurt Moyer from Pine Lake Laboratories, and Alan Golden from Design Quality Consultants.

Resource from this episode:

EU Medical Device General Safety and Performance Guidance – MDR

ANNEX 1 Guidance

FDA 21 CFR Part 4 – Subpart A – Current GMP for Combo Products

FDA 21 CFR Part 4 – Subpart B Post-marketing Safety Reporting for Combo Products

ICH Q9 QRM Guidance

ISO 10993 – 2018

ISO 11607 Sterile Barrier

Roberta Goode is an executive with over 25 years of experience in the medical device industry. She is currently President and CEO of Goode Compliance International, a global leader in engineering and compliance services for medical device manufacturers, specializing in process validation, design control and risk management. Prior to founding GCI’s medical device division in 1993, Ms. Goode held positions of increasing responsibility in R&D, Manufacturing and Quality Engineering at Beckman-Coulter Corporation, Althin Medical, Inc. (acquired by Baxter Healthcare), and Cordis Corporation (a Johnson and Johnson company), where she contributed intellectual property in the form of four US patents for percutaneous cardiovascular interventional devices. She holds a Master of Science degree in Biomedical Engineering and a Bachelor of Science degree from the University of Miami. Additionally, Ms. Goode has an adjunct faculty appointment at the University of Miami’s College of Engineering and is an ASQ Certified Quality Engineer.

Alan Golden is Principal at Design Quality Consultants, LLC where he works with clients training and advising on topics in the medical device industry including Design Control, Change Control, Risk Management and process/test method validation. Alan has more than 30 years’ experience working in the medical device industry. In addition to his expertise in Design Controls, he is also highly experienced in Good Laboratory Practice (GLP), 21 CFR 820, ISO 13485, ISO 14971, Biotechnology, and U.S. Food and Drug Administration (FDA) and risk management. He retired from Abbott Molecular in 2018. He can be reached at [email protected] 

Becky Leibowitz is Director of CMC Regulatory Affairs at Janssen and leads a team of regulatory professionals responsible for developing innovative CMC regulatory strategies for global drug-device combination product clinical trial and marketing applications.  At Janssen, Becky has been responsible for the device-specific sections of US and ROW regulatory submissions for single entity and co-packaged combination products, for new products in development and for post-approval changes.  Prior to Janssen, Becky developed biologic-device combination products and medical devices at ETHICON.  Becky holds both a BS and PhD in Mechanical Engineering.

Kurt L. Moyer, Ph.D. is currently the President of Pine Lake Laboratories and was the General Manager of Pine Lake Laboratories predecessor NSF Health Sciences for over 10 years. Prior to joining NSF Health Sciences, Dr. Moyer served as a Senior Research Investigator for Sanofi Aventis and a Research Scientist for the DuPont Pharmaceutical Company. Dr. Moyer holds a Ph.D. in Biochemistry from Villanova University and a BS in Biochemistry from Millersville State University. He may be contacted at [email protected] or at 860-940-6550. 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. 

This week, Stacey welcomes back Ivan Soto to discuss how the pandemic has impacted all businesses in the pharmaceutical and biotechnology industry across every functional area including validation. Downtime due to social distancing requirements, employee illness, and the close of many departments for on-site purposes have had a major impact on productivity and production. Although most companies in the industry have Business Continuity Plans, most of them were not detailed or inclusive enough to provide contingencies for all impacted functional areas. Today we will highlight strategies that enable validation leadership and teams to keep validation activities functional and productive not only throughout but following the pandemic.

Resources from this episode:

Keeping Validation Functional & Productive During A Pandemic - Article in Journal of Validation Technology, Vol. 26, Issue 6, December 2020

Placing Patient Safety First: Developing A Disaster Plan To Reduce Risks From Covid-19 Stability Program Impacts - Article in Journal of Validation Technology, Vol. 26, Issue 4, August 2020

Ivan Soto is the Director CQV at Emergent BioSolutions, he is responsible for leading the commissioning, qualification, and validation activities at the Canton Massachusetts manufacturing facility. He has been in the industry for over 20 years and has held several technical and management positions at different biotech and pharmaceutical companies in Validation, IT Compliance, Quality Control, Quality Assurance, Manufacturing, and Business Strategy. Ivan is also a contributing editor for the Journal of GxP Compliance and Journal of Validation Technology. He has a B.S. in Chemistry from the Pontifical Catholic University of Puerto Rico.

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

Disclaimer: The views expressed in this podcast are those of the guest alone and do not represent the views of Emergent BioSolutions.

This week, Stacey is joined by Nuala Calnan and Lori Richter to continue their series on Risk Revolution. Rob De La Espriella joins the show to share his insights and expertise on the need for critical thinking and complex problem-solving skills in getting to the root of the matter when we investigate, correct, and prevent failures.

Resources from this episode:

Root Cause Analysis – A Systematic Approach, JVT Article https://www.ivtnetwork.com/article/root-cause-analysis-%E2%80%93-systematic-approach

Addressing the Root Cause, Not the Symptoms: Root Cause Investigations for CAPA – Podcast - https://www.ivtnetwork.com/article/addressing-root-cause-not-symptoms-root-cause-investigations-capa

Getting to the Root of the Cause – BioPharm International article - http://www.ivtnetwork.com/sites/default/files/PRE PUB__BP0521_Getting to the root of the matter.pdf

Rob De La Espriella is a former nuclear submarine officer and the founder/owner of DLE Technical Services, LLC (DLE), and DLE has been a prime contractor for the Department of Energy since 2012. Rob is one of the leading experts in causal analysis, with over 30 years of experience in leading and facilitating root cause analyses, event investigations, and assessments at commercial nuclear power plants, the US Nuclear Regulatory Commission (NRC), the DOE, the US Department of Defense (DOD), and Engineering firms.

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

This week, Stacey welcomes back Chris Wubbolt to get a better understanding of the unique data integrity and validation oversight needed in virtual environments in a post-pandemic world. Stacey and Chris discuss the challenges for businesses of all sizes whether they use a hybrid or remote model.

Resources From This Episode:

FDA Provides Guidance on Remote Interactive Evaluations

COVID-19 - US Food and Drug Administration Guidelines

IVT's Annual Computer Systems Validation and Software Assurance Week Compendia

Chris Wubbolt, Principal, QACV Consulting

Chris has provided quality assurance and computer validation consulting services since 2001, specializing in validation of computerized systems, as well as quality assurance activities such as auditing, training, and quality improvement processes. Prior to becoming a consultant, Chris worked in Computer Systems Validation and Quality Assurance roles for Aventis Pasteur, Johnson & Johnson’s McNeil Consumer Products Company, and Lancaster Laboratories. He was a contributing member of the GAMP Laboratory Systems Special Interest Group, which published a guidance document on validation of laboratory systems, as well as a chapter chair for the DIA committee developing guidance on computerized systems used in clinical research. Chris can be reached by email at Chris Wubbolt [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 Chris Flask and they discuss how covid has impacted the drug supply chain, how the drug supply chain will look as we return to normal operations, and what the future has in store for this part of the industry.

Resources for this Episode:

1. New Bill Enacted Requiring Forecasting of Medical Device and Supply Shortages

2. FDA Drug Product Tracing Requirements – Overview

3. FDA Drug Product Tracing Requirements – The Bill

Chris Flask,

Global Business Capability Owner,

Roche Warehousing

With over 20 years in Pharma, Chris has held a variety of roles in Manufacturing, Strategic Development, and Supply Chain. All of these roles have required the development of Business Continuity Plans to ensure the continued supply of critical medicines to patients across the globe. Prior to his current role, Chris led the North America hub warehouse for Roche Drug Substance, managing the flow of $40 billion dollars worth of product annually.

Chris is currently the Global Business Capability Owner for Roche Warehousing. In this role, Chris is responsible for aligning the business processes used by over 60 warehouses worldwide. Chris holds a bachelor’s degree in Biochemistry from UCLA and a Master’s in Business Administration from UC Davis. Chris is a Black Belt in Lean/Six Sigma methodology and is Certified in Production Inventory Management by APICS.

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

This week, Stacey is joined by Karen Ginsbury to chat about the guidances available for the Quality Management System, the progression of regulatory guidance and expectations, whether or not they are helping or hindering the process, and how we can move forward with risk-based critical thinking.

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

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