Combination Products: Successful Product Development & Regulatory Anticipations & Complexities

Combination Products: Successful Product Development & Regulatory Anticipations & Complexities

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 – 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 [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 – 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 [email protected] or at 860-940-6550. He can be reached at [email protected]


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