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FDAnews - Fourth Annual FDA Inspections Summit

October 21 - 23, 2009 • Bethesda, MD


Beginning September 15, the FDA will expect you to file responses to Form 483s within 15 business days. No ifs, ands or buts. If you don’t, a warning letter will be issued — fast. Make plans to attend the Fourth Annual FDAnews Inspections Summit. With ten FDA officials in attendance, you will get straight answers directly from the source.

FDA Commissioner Hamburg has announced speedier, tougher FDA enforcement efforts. In a recent media briefing, she outlined six key enforcement steps, including setting timelines for responding to 483s and introducing the “close-out” letter — which she hopes will become a top industry priority.

Steven Niedelman is one of the speakers at this event. His topic is "Building Effective Supplier Control Programs and Reducing Risk."

Click for the event brochure [PDF]

Official Event Site

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