FDA Inspections and Enforcement Tools

Event Details

March 22, 2005
Noon – 2:15 EST

Topics covered: 

• 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.

Click here to download presentation materials for this web conference