The FDA in it’s Final Guidance urges companies to be “Recall Ready” to protect public health. Are you recall ready?

Secure your spot! Register for “New FDA Guidance Top Takeaways” live webinar July 19th, 2022 @ 12:00PM CT with Live Q&A.

Discover the latest on the The US Food and Drug Administration (FDA) finalized Voluntary Recall Guidance and how it could effect your company’s voluntary product recall readiness at all stages of a product’s distribution chain in food, drugs, devices, biological products, cosmetics, and tobacco.

Trievr Recall Management is dedicated to helping companies meet the necessary requirements with this sweeping new voluntary recall final guidance program which went into effect in March 2022. Don’t miss this important opportunity to learn from recall industry experts, Dr. Darin Detwiler and guest Dr. Stephen Amato as they bottom line the top takeaways from the FDA Voluntary Guidance 2022.

Host: Dr. Darin Detwiler, LP.D.
Special Guest: Dr. Stephen Amato, PhD
Time: 12:00P – 12:45P CT

Topics & Questions Covered:

• Understanding Voluntary Recalls
• What is FDA Recall Authority?
• What are the Differences Between Mandatory vs. Voluntary Recalls?
• What is the FDA Final Guidance and Who Does it Effect?
  • What Does Recall Ready Mean?
  • Top takeaways
• Live Q&A

Who Will Benefit

Personnel who are responsible for overall recall decisions and/or execution, particularly:

• Regulatory personnel
• Quality personnel
• Aspiring regulatory and quality leaders/senior leaders
• Members of recall Teams (from functional areas such as Operations, Service and Marketing)

Host: Dr. Darin Detwiler, LP.D.

Dr. Darin Detwiler is an author, advisor, consultant, and an Associate Teaching Professor of regulatory policy and corporate social responsibility at Northeastern University’s College of Professional Studies in Boston. His students have gone on to leadership positions in industry and in state and federal agencies. For nearly 30 years, he has played a unique role in controlling foodborne illness. Detwiler collaborated with the Secretary of Agriculture on USDA consumer education in the early 1990s, then served two appointed terms on the USDA’s National Advisory Board on Meat and Poultry Inspection. He has impacted FDA policy as the Senior Policy Coordinator for STOP Foodborne Illness, through service on Conference for Food Protection councils, and through his work with the FDA. Detwiler’s research and insights have appeared on television, industry magazines, and in books. He sits on numerous advisory and editorial boards and has long consulted on policy with industry in the U.S. and abroad. Dr. Darin Detwiler is the recipient of the International Association for Food Protection’s 2022 Ewen C.D. Todd Control of Foodborne Illness Award as well as their 2018 Distinguished Service Award. He is also a recipient of an AMGEN Biotechnology 2009 AASTE Award.

Guest: Dr. Stephen Amato, PhD

Dr. Stephen F. Amato has over 25 years of experience in the pharmaceutical, biotechnology and medical device industries. Prior to his position as Faculty Director of Graduate Regulatory Affairs and Life Sciences at Northeastern University, Steve was the Founder and Managing Director of tJun17 Life Sciences Advisors, LLC, and also a Managing Director for Cardinal Health Regulatory Sciences. Additionally, as an Executive with GfK Health, Dr. Amato managed and worked on client global regulatory affairs and reimbursement projects in the areas of market access, pricing, and payer coverage, coding and payment strategy. Prior to GfK Health, as an Executive Director at Anika Therapeutics, Steve managed all aspects of the company’s product portfolio including regulatory, reimbursement, market segmentation, targeting, positioning, pricing and promotional strategies. Dr. Amato’s research has been published in the Journal of Immunology and Cancer Research. He co-edited and wrote several chapters for the book, Regulatory Affairs for Biomaterials and Medical Devices, published by Elsevier Publishing in 2015.

Steve holds an AB in Biochemical Sciences from Harvard University, a Ph.D. in Molecular and Cellular Biology from Boston College’s Graduate School of Arts and Sciences, and an MBA from the Carroll School of Graduate Management at Boston College. He has also received the U.S. and EU Regulatory Affairs Certification designations and is a Consultant for the Regulatory Affairs Professional Society.