Compliance Architects® is particularly excited to announce CEO Jack Garvey’s participation in this year’s event as Moderator of, “Medical Product Facility Inspections and COVID-19: What is the Latest, and What Can Industry Expect Moving Forward?“ This engaging session is scheduled for Day 2 of the event starting at 1:30pm Eastern. Jack will be joined by…
Kalah Auchincloss, Executive Vice President and Deputy General Counsel, Greenleaf Health, Inc.
Elizabeth Miller, Assistant Commissioner for Medical Products and Tobacco, ORA, FDA
Vipul Sheth, Vice President, Quality and Regulatory Compliance, Becton, Dickinson and Company (BD)
Moderated by John (Jack) C. Garvey, Managing Partner, Compliance Architects LLC
In March 2020, FDA temporarily postponed all domestic and foreign routine surveillance facility inspections (excepting mission-critical inspections) because of the COVID-19 outbreak. Since, FDA has been utilizing its authority under 704(a)(4) to request and review records and resume prioritized domestic inspections. In April 2021, FDA released guidance on remote interactive evaluations (REIs). This session will delve into how and when REI’s will be used, what it means for companies, and areas of risk. Speakers will also address what new COVID-driven inspection practices may continue post-pandemic.
FDLI is excited to provide the key industry updates and the opportunity to connect with the food and drug law community that you have come to expect from the Annual Conference in a virtual format. While we will miss seeing each other in person, a virtual format allows the whole food and drug law community to participate regardless of safety concerns, location, time zone, or budget constraints. The Annual Conference will host an array of experts from the federal government, industry, the private bar, non-profits, patient and consumer advocates, and academia over the span of three shortened days to address the latest trends and updates in complex legal, regulatory, compliance, and policy issues currently impacting all facets of FDA-regulated industry.
Additional Conference Highlights:
- Hear FDA’s strategic priorities directly from the FDA Commissioner, Chief Counsel, Center Directors, and other key leaders within the Agency and the impacts of COVID-19 as we move through 2021
- Gain in-depth knowledge of each FDA Center by attending consecutive Center Director sessions scheduled to maximize attendee participation
- Join high-level colleagues in food and drug law to hear different viewpoints, shape policy, and advance understanding in the post-COVID era
- Select from over 30 breakout sessions covering the latest in legal, regulatory, compliance, policy, marketing, and related issues
- Learn from more than 100 well-known officials and experts
- Hear about the Top Cases in Food and Drug Law
- Network and build relationships with seasoned legal, regulatory, compliance, policy, and government professionals
Key FDA Speakers:
- Janet Woodcock, Acting Commissioner, FDA
- Mark Raza, Acting Chief Counsel, FDA
- Patrizia Cavazzoni, Acting Director, Center for Drug Evaluation and Research, FDA
- Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA
- Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition, FDA
- Jeffrey E. Shuren, Director, Center for Devices and Radiological Health, FDA
- Steven M. Solomon, Director, Center for Veterinary Medicine, FDA
- Mitchell R. Zeller, Director, Center for Tobacco Products, FDA
