Plenary 3: Compliance Office Updates

Moderator(s)

• 

  John Ayres, MD

  Risk Assessment Clinician
  Pharma Safety Solutions, LLC
  Nobelsville, Indiana, United States

Regulatory Panelist(s)

• 

  Donald Ashley, JD

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

  Cindy Burnsteel, DVM

  Deputy Director for Drugs and Devices, Office of Surveillance and Compliance, CVM
  U.S. FDA
  U.S. FDA
  Rockville, Maryland, United States
• 

  Alonza Cruse

  Director, Office of Pharmaceutical Quality Operations, ORA
  U.S. FDA
  Silver Spring, Maryland, United States
• 

  Melissa Mendoza, JD

  Acting Director, Office of Compliance and Biologics Quality, CBER
  U.S. FDA
  Kensington, Maryland, United States

Regulatory Presenter(s)

• 

  Donald Ashley, JD

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

  Presentation Handout
• 

  Cindy Burnsteel, DVM

  Deputy Director for Drugs and Devices, Office of Surveillance and Compliance, CVM
  U.S. FDA
  U.S. FDA
  Rockville, Maryland, United States

  Presentation Handout
• 

  Alonza Cruse

  Director, Office of Pharmaceutical Quality Operations, ORA
  U.S. FDA
  Silver Spring, Maryland, United States

  Presentation Handout
• 

  Melissa Mendoza, JD

  Acting Director, Office of Compliance and Biologics Quality, CBER
  U.S. FDA
  Kensington, Maryland, United States

  Presentation Handout

Featuring Office of Compliance leaders from the U.S. FDA Centers and Office of Regulatory Affairs, this session continues as one of the highlights of the Conference. In a virtual Roundtable format, U.S. FDA’s top leaders in Compliance and Enforcement will describe their programs, initiatives, and recent actions related to inspection and compliance. Current regulatory challenges and FDA’s current enforcement strategy for a wide array of medical products will be addressed. This is the best possible opportunity for you to understand U.S. FDA’s thinking and expectations for industry compliance. Most importantly, there will be ample time for the audience to ask questions of U.S. FDA’s senior leadership.

Presentations:

• 09:45 – 10:02 EDT

  CBER Compliance Updates
  

  Regulatory Presenter: Melissa J. Mendoza, JD – U.S. FDA
• 10:02 – 10:22 EDT

  CDER Compliance Updates
  

  Regulatory Presenter: Donald D. Ashley, JD – U.S. FDA
• 10:22 – 10:35 EDT

  CVM Compliance Updates
  

  Regulatory Presenter: Cindy L. Burnsteel, DVM – U.S. FDA
• 10:35 – 10:57 EDT

  ORA Compliance Updates
  

  Regulatory Presenter: Alonza E. Cruse – U.S. FDA
• 10:57 – 11:15 EDT

  Live Q&A (P3)
  

  Moderator: John D. Ayres, MD – Pharma Safety Solutions, LLC

  Regulatory Panelist: Donald D. Ashley, JD – U.S. FDA

  Regulatory Panelist: Cindy L. Burnsteel, DVM – U.S. FDA

  Regulatory Panelist: Alonza E. Cruse – U.S. FDA

  Regulatory Panelist: Melissa J. Mendoza, JD – U.S. FDA