Session: Plenary 4: Current GMP Compliance Trends and Topics

Live Q&A (P4)

Tuesday, September 28, 2021

12:44 – 13:15 EDT

New this year as a plenary, this perennial “standing room only” session will include presentations from CDER and CBER CGMP managers that are designed to provide insights beyond the usual “Top 10” 483 observations. Attendees will learn about major CGMP issues and notable warning letters. These presentations will be followed by a discussion with Center and ORA panelists.

Moderator(s)

David L. Chesney, MSJ

Principal and General Manager
DL Chesney Consulting, LLC
Cumberland Foreside, Maine, United States

Regulatory Panelist(s)

Maria C.H. Anderson, MS

Branch Chief, Biological Drug and Device Compliance Branch, CBER
U.S. FDA
Silver Spring, Maryland, United States
Monica L. Casey, RVT

Consumer Safety Officer, CVM
U.S. FDA
Rockville, Maryland, United States
Francis RW Godwin, MBA

Office Director, OC, CDER
U.S. FDA
Silver Spring, Maryland, United States
Nicholas F. Lyons, MS

Director of Compliance, Office of Pharmaceutical Quality Operations, ORA
U.S. FDA
Chicago, Illinois, United States