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:
- The “In-Plant Photographs” section has been revised to address how investigators will respond when a firm refuses photography during an inspection.
- Environmental sampling policies have been simplified and revised.
- New Re-Inspection User Fee procedures have been incorporated, as mandated under the Food Safety Modernization Act.
- Tobacco product guidance has been included throughout.
- Contact information and FDA directories are updated.
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.
Place your order today.
Get insider information on:
- Cooperative efforts by state and federal inspection agencies
- Sampling techniques
- Import procedures
- Types of investigations
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.
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