Each year, the FDA makes adjustments to its inspection processes and policies.
In addition to the routine technical updates, the FDA has made the following important changes:
An inspection doesn’t have to be full of surprises … as long as you know the rules that inspectors will be operating under before they walk in the door.
Now you can have the inspection manual
that the FDA inspectors use.
From FDAnews — Investigations Operations Manual 2013 — the FDA’s own internal guidance on how to inspect a drug or device company.
Know what the investigators will look for — before they even get there. Know the inspectors 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 readying yourself to know and abide by the FDA’s own inspection guidelines.
At FDAnews, we remove all the extraneous material from the manual—the food and tobacco regulations that you don’t care about. We leave in just the important sections that drug, device and biologics makers need. You won’t have to hunt for the material that matters; we’ve done the work for you.
Available directly from FDAnews, the Investigations Operations Manual 2013 is the primary source FDA field investigators and inspectors use to conduct field investigations.
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Make sure you’ve got the latest version before the FDA knocks on your door.
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