October 24-25, 2022 | 2-Day Digital Conference
Digital Conference8:00AM EST // 1:00PM BST // 2:00PM CESTkeyboard_arrow_right
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Day Two - EST/EDT (Eastern Daylight, GMT-4)
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Day Two - EST/EDT (Eastern Daylight, GMT-4)
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Day 2 - 25th October
09:00 - 09:15
Welcome Remarks
09:15 - 09:45
FDA Update: Understanding Recall Regulations
- Catherine M. Beer - Commander, U.S. Public Health Service Division of Enforcement Director, Division of Enforcement (DE), Office of Strategic Planning and Operational Policy (OSPOP), Office of Regulatory Affairs (ORA), U.S. Food and Drug Administration, USA
09:45 - 10:15
Guidelines for Recall Reporting
- Stephanie L. Leppo - Quality Associate Director, Zimmer Biomet, USA
10:15 - 10:45
Recall Case Study in an IDN
- Thomas Martin - Recall Specialist, Sentara Healthcare, USA
10:45 - 11:15
Coffee Break & Networking
11:15 - 11:45
Working with the FDA on Recalls
- Ashley Kelleher - Senior Medical Device Consultant, Medical Devices and IVDs, NSF, USA
11:45 - 12:15
Health Hazard Evaluations – What to Consider and Actions
- Beverly H. Lorell - Senior Medical & Policy Advisor FDA & Life Sciences Group, King & Spalding LLP, USA
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