The Quality System Compendium: GMP Requirements & Industry Practice, 2ed
This new version combines the first edition of The Quality System Compendium and the Supplement to The Quality System Compendium into a single volume, and provides updated and new information on critical regulatory areas that have seen significant changes in the years since both textbooks were published.
Updates include:
- New chapters on combination products and risk management for medical devices.
- An updated chapter on FDA's organization and regulatory strategies, including the recent reauthorization of MDUFMA.
- Revised chapters on quality systems, design controls, and process validation, to reflect current FDA and industry thinking.
- A bibliography that includes current references and websites.
- A full copy of the Final Rule for the Quality System regulation, including a list of all Technical Amendments published since 1996.
- A comprehensive index.
- User-friendly tabs for easy navigation.
The QS Compendium is available in print, CD, or as a set.
| Order Information: | Order
Code |
Member
Price |
List Price |
Buy Now |
| Quality System Compendium | QSC |
$385 |
$500 |
 |
| Quality System Compendium CD | QSC-CD |
$385 |
$500 |
|
| Quality System Compendium Book / CD Set | QSC-S |
$585 |
$695 |
|
Or order by phone at +1-877-249-8226 or +1-240-646-7031.