Session: Plenary 3: Compliance Office Updates

Live Q&A (P3)

Tuesday, September 28, 2021

10:57 – 11:15 EDT

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.

Moderator(s)

John D. Ayres, MD

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

Regulatory Panelist(s)

Donald D. Ashley, JD

Director, Office of Compliance, CDER
U.S. FDA
Silver Spring, Maryland, United States
Cindy L. Burnsteel, DVM

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

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

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