Investigations Operations Manual 2014

Investigations Operations Manual 2014

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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:

  • New guidance that tells investigators exactly when to walk through the facility during inspections,
  • Detailed instructions on how to write inspection reports so they better serve as proof of violations,
  • New, required elements that must be included in ALL inspection reports for NAI, VAI and OAI findings,
  • New instructions for creating exhibits to inspection reports that will support evidence of violations,
  • Completely up-to-date FDA contact information,
  • And more…

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
that the FDA investigators use.

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:

  • Cooperative efforts by state and federal inspection agencies
  • Sampling techniques
  • Import hold procedures
  • Recalls
  • Types of investigations
  • And more…

Make sure you’ve got the latest version before the FDA knocks on your door.

Order Your Copy Today!

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Table of Contents

  • 1-Administration
  • 2-Regulatory
  • 3-Federal and State Cooperation
  • 4-Sampling

View the entire TOC

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Get Multi-user Access With The Electronic Books Library.
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. Contact customer service for a quote or more information.

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