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 PUBLICATION LIST