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The Investigations Operations Manual is the primary policy guide for FDA investigations and directs the conduct of all fundamental field investigational activities. Adherence to the manual is required.
Now you can have the same investigation manual
Know what the investigators look for — before they even get there. Know the investigators’ expectations and rights. Find and fix problems before they end up on a Form 483 or warning letter.
There is no better way to prepare for an inspection than studying the actual procedures the FDA teaches its investigators.
Available directly from FDAnews, the newly updated edition of the Investigations Operations Manual 2016 is the primary source FDA investigators use to conduct field inspections.
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