March 22, 2005
Noon – 2:15 EST
- Overview of FDA Inspection and Enforcement Authority
- Inspection Readiness- Key Steps For Avoiding Enforcement Actions
William H. Kitchens, Partner, Food & Drug Practice Team, Arnall Golden Gregory LLP – Atlanta, Georgia
- What does your company look like to FDA, what is your regulatory profile?
- When is your next FDA inspection?
- How do you know your team is prepared?
- What can you do if the inspection is not going well?
Mark Lynch, Director, PAREXEL Consulting and former Director of Investigation and Preapproval Compliance Branch, Office of Compliance, CDER, FDA – Rockville, Maryland
- Some Practical Pointers About Communications During the Inspection and On-the-Ground Preparation
- The Impact of Recent FDA Initiatives: Systems Approach, Tech Dispute, Risk-Based Inspection Model
- Post-Inspection: The Most Important Part May Be After the Inspector Leaves
Zena G. Kaufman, Senior Director, Regulatory Compliance Initiatives, Pfizer, Inc. – New York, New York
Moderated by Alan G. Minsk, Leader, Food & Drug Practice Team, Arnall Golden Gregory LLP – Atlanta, Georgia
Cost is only $75 per location.
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