FDA Inspections and Enforcement Tools

Event Details

Schedule

March 22, 2005

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Location

Internet

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.



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