Full Description

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.

CD is not printable

Product Details

Edition: 2nd