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#21: FDA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them, and How to Respond If Violations Do Occur

Tutorial name:
#21: FDA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them, and How to Respond If Violations Do Occur

Day & Time:
June 24, 8:30AM - 12:00PM

Room Number:
123

Description:
Maximize your learning while attending the DIA 2012 Annual Meeting! Receive $100 off of your DIA 2012 meeting registration by registering for two half day tutorials (#20-34) or one full day tutorial (#40-48). Purchases must be made at the same time in order to receive the discount.

This tutorial will review and discuss the legal, regulatory, and practical challenges of (1) FDA enforcement priorities for 2012 and beyond (e.g., application integrity policy and GMP/GCP requirements), (2) FDA administrative enforcement weapons and how the Agency uses them (e.g., inspections, warning letters, publicity, recalls, and investigator disqualification proceedings), and (3) the civil and criminal penalties for violations (e.g., seizure, injunction, criminal prosecution). Included in our focus will be FDA's renewed commitment to enforcement as articulated in an August 2009 speech by Commissioner Margaret Hamburg. We also will address how to handle an FDA enforcement action should you face one, particularly in the wake of an inspection or Warning Letter and the impact of the new initiatives related to responding to 483s and Warning Letters implemented in 2009 following Commissioner's Hamburg's pledge to boost enforcement. These 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.

Learning Objective(s):
At the conclusion of this tutorial, participants should be able to:

•Discuss FDA's enforcement priorities for 2012 and beyond

•Describe FDA's compliance review and decision-making process

•Identify the legal risks and penalties for noncompliance

•Respond appropriately to FDA enforcement



Target Audience:
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.

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