Don’t wait for FDA inspectors to tell you about changes to the agency’s inspections manual when they’re already at your facility ...
Each year, the FDA makes adjustments to its inspection processes and policies. This year is no exception.
In addition to a host of technical and procedural 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 same inspection manual
for 2012 that the FDA inspectors use.
Just released from FDAnews — Investigations Operations Manual 2012 — 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.
Available directly from FDAnews, the newly updated edition of the Investigations Operations Manual 2012 is the primary source FDA field investigators and inspectors use to conduct field investigations.
Get insider information on:
Make sure you’ve got the latest version before the FDA knocks on your door.
Offering the FDA’s own most up-to-date official guidance, the Investigations Operations Manual 2012 helps you stay in compliance despite changing policies and tougher-than-ever enforcement.
Available in both print and CD-ROM formats:
There's no risk when you purchase from FDAnews with our money-back guarantee. Not satisfied with your publication? Return the hard copy within 30 days (in resalable condition), and we will refund 100 percent of your purchase price (less shipping/handling). For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase to receive a refund.
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