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.
- 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.
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