WHEN LIGHTNING STRIKES
Overview of FDA warning letters
and what to do if you get one.
The Biomedical Consortium presents WHEN LIGHTNING STRIKES a presentation coveringwhatis (and is not) a warning letter, the possible consequences, and what to do to avoid/correct these violations. These matters are of vital interest to all medical device companies.
Presenters: Tim Philips / Robert J. Klepinski
Mr. Philips is a Compliance Officer with the FDA and is a frequent speaker at industry and FDA-sponsored medical device programs.
Mr. Klepinski - is an Officer with Fredrikson & Byron and practices in the Food, Drug & Medical Device Regulation, Health Care Fraud & Compliance and Intellectual Property Groups.
