Don’t wait for FDA investigators to tell you what their new focus is when they’re already at your facility.
Each year, the FDA makes adjustments to its inspection processes and policies. This year is no exception.
Here are the FDA’s most important changes:
An investigation doesn’t have to be full of surprises … as long as you know the rules that investigators will be operating under before they walk in the door.
Now you can have the same investigation manual
for 2014 that the FDA investigators use.
Just released from FDAnews — Investigations Operations Manual 2014 — the FDA’s own internal guidance on how to inspect a drug or device company.
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 investigation than readying yourself to know and abide by the FDA’s own investigation guidelines.
Available directly from FDAnews, the newly updated edition of the Investigations Operations Manual 2014 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 2014 helps you stay in compliance despite changing policies and tougher-than-ever enforcement.
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