Plenary 4: Current GMP Compliance Trends and Topics

Moderator(s)

• 

  David Chesney, MSJ

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

Regulatory Panelist(s)

• 

  Maria Anderson, MS

  Branch Chief, Biological Drug and Device Compliance Branch, CBER
  U.S. FDA
  Silver Spring, Maryland, United States
• 

  Monica Casey, RVT

  Consumer Safety Officer, CVM
  U.S. FDA
  Rockville, Maryland, United States
• 

  Francis Godwin, MBA

  Office Director, OC, CDER
  U.S. FDA
  Silver Spring, Maryland, United States
• 

  Nicholas Lyons, MS

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

Regulatory Presenter(s)

• 

  Maria Anderson, MS

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

  Presentation Handout
• 

  Francis Godwin, MBA

  Office Director, OC, CDER
  U.S. FDA
  Silver Spring, Maryland, United States

  Presentation Handout

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.

Presentations:

• 11:45 – 12:16 EDT

  CDER/OC/OMQ Update
  

  Regulatory Presenter: Francis RW Godwin, MBA – U.S. FDA
• 12:16 – 12:44 EDT

  CBER Compliance Update
  

  Regulatory Presenter: Maria C.H. Anderson, MS – U.S. FDA
• 12:44 – 13:15 EDT

  Live Q&A (P4)
  

  Moderator: David L. Chesney, MSJ – DL Chesney Consulting, LLC

  Regulatory Panelist: Maria C.H. Anderson, MS – U.S. FDA

  Regulatory Panelist: Monica L. Casey, RVT – U.S. FDA

  Regulatory Panelist: Francis RW Godwin, MBA – U.S. FDA

  Regulatory Panelist: Nicholas F. Lyons, MS – U.S. FDA