What is the appropriate response to FDA enforcement?

FDA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them and How to Respond if Violations Do Occur
June 23 from 8:30AM – 12:00PM in Boston

This tutorial is designed for all personnel responsible for ensuring compliance with FDA requirements, particularly those under the GMP and GCP rules, regardless of whether in a supervisory or direct role. This tutorial will review and discuss the legal, regulatory, and practical challenges of (1) FDA enforcement priorities for 2013 and beyond; (2) FDA administrative enforcement weapons and how the Agency uses them; and (3) the civil and criminal penalties for violations. Interactive discussions will focus on how FDA operates and makes decisions and how to respond effectively, using tactics ranging from negotiation to, when appropriate, litigation.

Instructor:
Michael A. Swit, JD
Special Counsel
Duane Morris, LLP, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

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