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EVENT DATES
Oct 2015
MoTuWeThFrSaSu
   1234
567891011
12131415161718
19202122232425
262728293031 
EXHIBITION HALL DATES
Oct 2015
MoTuWeThFrSaSu
   1234
567891011
12131415161718
19202122232425
262728293031 

Venue

Venue TBD Washington , District of Columbia
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FDA inspections - How to Prepare, Manage and Respond - an Inspectional Lifecycle Approach

15 0

Overview

This two-day seminar will prepare firms to better manage an FDA inspection and designing/implementing a corrective action plan if FDA threatens to take punitive action against them. Included are segments on FDA Law, how to prepare for the inspection, how to prepare your subject matter experts (SME’s), how to manage interactions with the FDA and how to respond to an FDA 483/Warning Letter/Injunction/Seizure/Import Bans. Case Studies and Templates are included. Pharmaceutical, Medical Device, Human Tissue, and Combination Product are covered.

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