Voices In Validation
CSV: Digital Transformation Initiative

CSV: Digital Transformation Initiative

July 27, 2021

In this episode, we will hear an exclusive conversation from the recent CSV Virtual Event, "Digital Transformation Initiative" This discussion was moderated by Daniel Matlis and features Sam Cheemokati, Paul Hurlocker, and Ron Schardong. 

The discussion will be focused on exploring organization-wide digital transformation initiatives. The panel will share their firsthand experiences of point solutions to platforms transitions. And, the best practices when shifting to cloud computing and the cloud-first approach.

About the panel:

Daniel Matlis

Daniel R. Matlis is the Founder and President of Axendia – a trusted advisor to Life-Science and Healthcare executives on business, technology, and regulatory issues.

Dan’s career in the industry spans over 20-years and has included projects in research & development, manufacturing, regulatory compliance, business development and information technology.

Prior to founding Axendia, Dan was General Manager & VP at Stelex (now a GE company) – a leading consultancy to life-science companies.

He started his professional career at Ethicon, Inc., a Johnson & Johnson Company.

 

Sam Cheemakoti

Sam is the GMP Head at Beiersdorf for the Coppertone Division overseeing GMP compliance of its computer and automated systems. Sam has held positions of increasing responsibility at various Pharmaceutical companies such as Bayer, Merck, and Schering Plough in the areas of Computer Systems Validation, IT Compliance, and Quality Assurance. As a Quality leader with 20+ years in the industry with a demonstrated ability to produce and deploy Part 11 and Data Integrity remediation programs, validation programs, quality systems, strategic initiatives for Quality and Compliance especially under conditions of the consent decree, acquisitions, and divestitures has lent him unique perspectives as a change ambassador and thought leader. Sam earned his MS in Industrial Engineering from Louisiana Tech University and his Project Management credentials from Villanova University. He more recently completed a course on Digital Transformation: Leading People, Data and Technology from the University of Berkeley under their Executive Education Program in order to gain synergies between the two journeys of Digital Transformation and Computer Software Assurance for Quality. 

 

Paul Hurlocker

Paul is the CTO at Spring Oaks Capital, a technology-driven financial services company whose mission is to reinvent the debt recovery industry by providing a customer-centered user experience and streamlined operations powered by data and machine learning. Paul previously served as the Senior Director and Vice President of the Center for Machine Learning for Capital One. Paul founded Notch, Co and served as the CEO before selling the company to Capital One.

Ron Schardong

Ron is privileged to lead Johnson & Johnson’s Technology Quality group responsible for computerized systems validation of business applications in the Medical Devices, Consumer, and Pharmaceutical segments worldwide. The applications include ERP, Warehouse Management, Manufacturing, Laboratory, Quality Systems, Clinical, R&D, Enterprise Tools, Services, and Infrastructure. He has over 25 years of experience in quality engineering, supplier quality, quality auditing, quality management, regulatory compliance, and regulatory affairs. Ron is one of the original members of FICSA Group (FDA + Industry Computer Assurance Group).
 
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. 
Working in Life Sciences: Talent Recruitment, Retention & Engagement

Working in Life Sciences: Talent Recruitment, Retention & Engagement

July 20, 2021

This week, Stacey is joined by Robin Toft to talk about the challenges of attracting and hiring top talent, tactics for building and retaining a workforce, and the technologies that are changing the ways we recruit, hire, and train our teams. Stacey and Robin also discuss which areas are in the most demand, talent management strategies, career path planning, and much more.

Resources from this episode:

Talent 2020: Surveying The Talent Paradox From The Employee Perspective: The View From The Life Sciences Sector https://www2.deloitte.com/content/dam/Deloitte/mx/Documents/human-capital/Talent_2020_LifeSciences.pdf

WE CAN: The Executive Woman's Guide to Career – on Amazon https://www.amazon.com/WE-CAN-Executive-Womans-Advancement/dp/1949635031

WE CAN: The Executive Woman's Guide to Career – on Goodreads https://www.goodreads.com/book/show/43533323-we-can

We Can Rise Community https://wecanrisecommunity.com/

About Our Guest:

Robin Toft is the founder and CEO of Toft Group a ZRG Company, where she combines a deep inside knowledge of the life science industry with a passion for building game-changing management teams. A champion of diverse executive teams, Robin has built a reputation for recruiting women and minorities into top roles and helping the life science industry overcome unconscious bias in hiring. Having successfully sold Toft Group to ZRG Partners, Robin co-founded We Can Rise in 2020, a B-corporation aimed at helping aspiring female executives to confidently reach their potential while achieving balance and collaborating to build healthier companies that change the world. Prior to founding Toft Group in 2010, Robin served 20+ years as a biotech executive. Robin’s first book entitled WE CAN, The Executive Woman’s Guide to Career Advancement, is recognized within the list of 100 Best CEO Books of All Time by BookAuthority and won Gold for Best E-book in the International Business Awards. In the American Business Awards for 2020, Robin won Gold in the three major individual categories of Lifetime Achievement, Maverick of the Year, and Woman of the Year. She also won Gold for Most Innovative Woman of the Year in the Women in Business Awards for 2020.

Robin currently serves on the boards of T2 Biosystems, Syapse, California Life Science Association (CLSA), The Clearity Foundation, and LEAD San Diego. Robin holds a B.S. in Medical Technology from Michigan State. 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: From Dreading the Risk Process to Living the Risk Life

Risk Revolution: From Dreading the Risk Process to Living the Risk Life

July 13, 2021

This week our series coordinators, Lori and Nuala, invite their guest Amanda McFarland to chat about Living the Risk Life. How do we take our colleagues on a journey from dreading their participation in the risk process to actually living a work-life and culture that embraces risk management?

Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. This series aims to advance the maturity of risk management practices within the industry, addressing topics that challenge quality professionals to seek opportunities to improve and advance how they perceive and manage risk.

Resources from this episode:

12 Inclusive Behaviors - The Kaleel Jamison Consulting

How To Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis

Amy Edmondson – TED TALK, Psychological Safety

About Our Guest:

Amanda McFarland - Senior Consultant at Valsource

Amanda assists companies with the design and implementation of CGMPs, Microbiology, and Quality Risk Management programs. Amanda specializes in creating and implementing risk management training programs, developing custom risk-based strategies, and risk facilitation.

 

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. 

 

Quality Systems Monitoring Reaction w/Valarie King-Bailey

Quality Systems Monitoring Reaction w/Valarie King-Bailey

July 6, 2021

In this episode, Stacey is joined by Valarie King-Bailey to discuss some of the key topics from the recent CSV panel on "Excellence and Next-Generation Approaches to Quality System Monitoring." The panel provided 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. Valarie will share his perspective on these topics as an industry expert. 

About our Guest

Valarie King-Bailey is the CEO of OnShore Technology Group, an independent Chicago-based consultancy specializing in Independent Validation and Verification (IV&V) products, and solutions.  OnShore’s product, ValidationMaster™ is the first fully integrated Enterprise Validation Management system on the market.  ValidationMaster™ was recognized by CIO Review Magazine as one of the top 20 most promising technologies for life sciences in 2015. OnShore led the development of the first FDA Validation Toolkit for Microsoft Dynamics AX and Microsoft NAV. Valarie has worked for leading global companies such as QUMAS Limited (Ireland), EMC/Documentum, Abbott Laboratories, and U.S. Steel – South Works.  At QUMAS, an Irish-based software company, she served as Chief Marketing Officer. She was responsible for all global tactical and strategic marketing initiatives and the development of their validation toolkit.  Valarie founded OnShore Technology Group in 2004.  OnShore Technology Group recently won the American Express/Count Me In M3 Award and the Madam C.J. Walker Outstanding Business Award (2008).   She also received a nomination for the Ernst & Young Entrepreneur of the Year award in 2006. Ms. King- Bailey holds an M.B.A. in Information Systems from Keller Graduate School of Management (1985) and a B.S. in Civil and Environmental Engineering from Wisconsin–M Madison (1982).   She is a member of the American Society of Civil Engineers, Society of Women Engineers, National Girls Collaborative Project for STEM education, Regulatory Affairs Professional Society (RAPS), and a U.W. College of Civil Engineering Advisory Board Member. She can be reached at vkbailey@onshoretech.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. 

 

 

CSV: Excellence and Next Generation Approaches to Quality System Monitoring

CSV: Excellence and Next Generation Approaches to Quality System Monitoring

June 29, 2021

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

Head of Global Quality Strategy Data and Vendor Management at Merck KGaA, Darmstadt, Germany
 
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. 
Quality Management Maturity – A Pilot Program of the FDA

Quality Management Maturity – A Pilot Program of the FDA

June 22, 2021

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

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.

Jennifer Maguire, Ph.D.

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.

Nandini Rakala, Ph.D.

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

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 Lundi

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. 

Risk Revolution: Facilitator - Friend or Foe?

Risk Revolution: Facilitator - Friend or Foe?

June 15, 2021

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. 

Drug Naming and Medication Errors

Drug Naming and Medication Errors

June 8, 2021

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.

Resources for this Episode:

Articles:

  1. Medication Safety: Industry Considerations Part 1 - Problem Overview https://www.ivtnetwork.com/article/medication-safety-industry-considerations-part-1-problem-overview 
  2. Regulatory 101: Medication Safety - Industry Considerations, Part 2, Drug Names https://www.ivtnetwork.com/article/regulatory-101-medication-safety-industry-considerations-part-2-drug-names
  3. Regulatory 101: Drug Name Modifiers – Definition, Categories, Generics, And CAPA https://www.ivtnetwork.com/article/regulatory-101-drug-name-modifiers-%E2%80%93-definition-categories-generics-and-capa
  4. Regulatory 101: Biologic Non-Proprietary Drug Names – Terminology And Format https://www.ivtnetwork.com/article/regulatory-101-biologic-non-proprietary-drug-names-%E2%80%93-terminology-and-format 
  5. Medication Safety And Drug Names - Valproic Acid Product Problems https://www.ivtnetwork.com/article/medication-safety-and-drug-names-valproic-acid-product-problems

References:

  1. FDA.  Guidance for Industry.  Best Practices in Developing Proprietary Names for Drugs. https://www.fda.gov/media/88496/download 
  2. FDA.  Contents of a Complete Submission for the Evaluation of Proprietary Names.  https://www.fda.gov/media/72144/download 
  3. FDA.  Safety Considerations for Product Design to Minimize Medication Errors.  https://www.fda.gov/media/84903/download 
  4. FDA. Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.  https://www.fda.gov/media/85879/download 
  5. Medicines & Healthcare products Regulatory Agency (UK MHRA).  MHRA Guideline for the Naming of Medicinal Products and Braille Requirements for Name on Label. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/810914/MHRA_Guideline_for_the_Naming_of_Medicinal_Products_and_Braille_Requirements_for_Name_on_Label.pdf.%C2%A0
  6. European Medicines Agency (EMA).  Guideline on the acceptability of names for human medicinal products processed through the centralized  procedure. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf.
  7. Health Canada.  Guidance Document for Industry.  Review of Drug Brand Names.  https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-document-industry-review-drug-brand-names.html
  8. Health Product Regulatory Authority (Ireland).  Guide to Invented Names of Human Medicines.  file:///D:/HPRA%20Drug%20names.pdf
  9. To Err is Human:  Building a Safer Health System.  Institute of Medicine, National Academic Press, Washington, DC, 2000.  https://www.ncbi.nlm.nih.gov/books/NBK225182 
  10. Preventing Medication Errors.  Institute of Medicine.  National Academic Press., Washington, DC, 2007. https://www.nap.edu/catalog/11623/preventing-medication-errors 

Karen R. Zimm, Ph.D. 

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 L. Pluta, Ph.D.

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 paul.pluta@comcast.net.

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. 

 

Combination Products: Successful Product Development & Regulatory Anticipations & Complexities

Combination Products: Successful Product Development & Regulatory Anticipations & Complexities

June 1, 2021

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

ABOUT OUR GUESTS:

ROBERTA GOODE - Moderator

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 – Panelist

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 alangolden.dqc@gmail.com 

BECKY LEIBOWITZ - Panelist

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 – Panelist

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 kmoyer@pinelakelabs.com or at 860-940-6550. He can be reached at kmoyer@pinelakelabs.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. 

Functional and Productive Validation During a Pandemic and Beyond

Functional and Productive Validation During a Pandemic and Beyond

May 25, 2021

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.

 

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