FDA Inspections, 483's and Warning Letters: How to Avoid and Survive Them

Are you doing FDA regulated research on drugs or devices?  Come to this lecture to hear about recent FDA visits at our institutions and elsewhere.  We will review how these visits work, discuss problems encountered by investigators, and how to avoid them.  When and why do they come?  What should I expect on an FDA visit? How should I prepare?  What are a Form 483 and a Warning Letter?  What do I do once I have one?  We will provide specific quotations from 483's and warning letters and help you understand how to respond, and better yet, how to avoid these. This lecture is strongly recommended for new research fellows and study coordinators, though all investigators and study staff, experienced or new, will benefit from attending this offering.

Harvard Medical School is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.  Harvard Medical School designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit™.  Physicians should only claim credit commensurate with the extent of their participation in the activity.

This program meets the requirements of the Board of Registration in Nursing, at 244 CMR 5.00, for 1 contact hour of nursing continuing education.