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 |
$365 |
$435 |
|
| Quality System Compendium CD |
QSC-CD |
$365 |
$435 |
|
| Quality System Compendium Book / CD Set |
QSC-S |
$585 |
$695 |
|
Or order by phone at 1-877-249-8226 or 240-646-7031.
RETURN TO BOOKS and CDS |
