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Avoiding A Warning Letter in FDA's New Enforcement Environment

October 5 - 6, 2010


Baker, Donelson, Bearman, Caldwell & Berkowitz, PC
920 Massachusetts Avenue, NW
Suite 900
Washington, DC 20001


October 5 - 6, 2010

In a recent speech at the Food and Drug Law Institute, FDA Commissioner Margaret Hamburg announced her intention to protect the public health by improving the effectiveness of FDA's enforcement system. Medical device firms now are reporting that FDA investigators are being more assertive when inspecting firms, increasing the number of 483 observations and issuing warning letters. This conference will provide you the tools necessary to avoid warning letters and enable you to demonstrate your compliance initiatives.

Who Should Attend:
Regulatory Professionals
Senior Level Management
Medical Device Professionals

Topics Covered:
Criteria FDA Uses to Determine What Items to List on a 483 and When the Agency Will Issue a Warning Letter
David R. Kalins, Consumer Safety Officer, Special Assistant to
the Director of the Office of Compliance, CDRH

Inspections Workshop
Betty Collins, former Director, FDA Office of Enforcement
Judy Meritz, Shareholder, Baker Donelson

Lessons Learned in Creating Solid SOPs and Conducting and Documenting Effective Measurable Training on Those SOPs
Nicole Petty, Senior Manager, Learning & Development, Stryker Instruments

Hands-On Interactive Session: How to Respond to 483s and Warning Letters
Judy Meritz, Shareholder, Baker Donelson

How to Determine FDA's Inspection Priorities Using the Freedom of Information Act
Marlene Bobka, Vice President - Marketing, FOI Services

How to Write CAPA Records to Reflect Your Compliance Initiatives
Tim Mohn, Sparta Systems and former Manager, Worldwide Quality Systems, Johnson and Johnson Ortho-Clinical Diagnostics
Nancy Singer, former Special Counsel, AdvaMed

Lessons Learned on Handling an FDA Inspection
Javad Seyedzadeh, Senior Vice President Global Quality
Assurance & Regulatory Affairs, Gambro

How to Avoid Common Mistakes During an FDA Inspection
FDA Investigator (invited)

Events Contact

Heather Stripling
T: 205.250.8332
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