Investigations Operations Manual 2015

$377.00
Quantity Discounts
1 - 2
$377.00
3 - 4
$339.00
5 - 6
$320.00
7 - 9
$302.00
10 - 9999
$283.00
Also Available:
Don’t wait for FDA investigators to tell you what their new focus is when they’re already at your facility. Get a heads up with the…

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:

  • Completely up-to-date information on the FDA’s new inspectorate structure as well as contact information;
  • New information on recalls, particularly correction and removal of medical devices;
  • Updated information on how the agency will detain drugs and devices;
  • 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
for 2015 that the FDA investigators use.

Just released from FDAnews — Investigations Operations Manual 2015 — 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 2015 is the primary source FDA field investigators and inspectors use to conduct field investigations.

Get insider information on:

  • 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!

PDF Edition

Print Edition

 

Available Formats

PDF Edition – $377
 
Print Edition – $377

(Add $10 shipping and handling per book for printed books shipped to the US or $35 per book for books shipped elsewhere. VA residents, please add 6 percent sales tax.)

Table of Contents

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

View the entire TOC

Multi-user Access

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 FDAnews Online Library – a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.

Our Guarantee

Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price. Return the hard copy within 30 days (in resalable condition) to receive your refund (less shipping/handling).