Brand new for 2018 -- the GMP Validation Handbook with DVD of important new compliance documentation! Now discounted! $695 plus shipping
This wildly popular manual was last updated in 2017, which had 800 pages of valuable FDA, EMA, ICH and other organizational guidance to help you ensure your quality system is in tip-top shape BEFORE FDA comes in to inspect.
The 2018-19 edition has some 300 MORE pages of important guidance on OOS, lab investigations, process validation, cleaning validation, AND ICH Q4B Annex 2 documents that are vitally important to keep in compliance with FDA and EMA inspections.
In addition, the Book has special guidance on data integrity and out of specification (OOS) and lab investigation reporting.
These documents are provided in a SPECIAL SUPPLEMENT in the printed bound edition, and all documents in the book are available in PDF on the DVD!
This new book contains:
* All FDA Guidance and compliance references on validation -- including, computer and software validation, cleaning, analytical methods -- and more
* ICH, EMA, documents
* Articles from WIS newsletters on how to -- and how not -- to validate your processes
Ensure your product integrity is in tact -- Order The 2018 "GMP Validation Handbook" and save.
FREE with your subscription is a six-month subscription to GMP/Supply Chain Report.
But if you subscribe to GMP/Supply Chain Report you will receive the GMP Validation Manual AND FDA Lab Controls Compliance Answerbook FREE - Learn more by calling us at (703) 779-8777 or email us at Service@FDAINFO.com Or, click here: http://www.fdainfo.com/index.php?id=vt