Quality Risk Management in the FDA-Regulated Industry

By Jose (Pepe) Rodríguez-Pérez

"Risk-based thinking and processes are increasingly important for all organizations, including those regulated by the FDA. This book is an essential guide to a systematic and comprehensive approach to quality risk management. The revised content in this third edition offers an updated view of the risk management field as it applies to FDA-regulated products: how to integrate risk management principles and activities into an existing QMS, remain in compliance with ISO 9001:2015 and ISO 13485:2016, and integrate three key and recently updated guidelines [ICH Q9(R1), ISO 14971:2019, and ISO 22000:2018]. Also includes practical explanations and plenty of helpful case studies and examples"-- Provided by publisher.

• Format: Paperback
• Language: English
• ISBN: 1636941559
• ISBN13: 9781636941554
• Release Date: December 2024
• Publisher: ASQ Quality Press
• Length: 312 Pages
• Weight: 0.92 lbs.
• Dimensions: 0.7" x 6.0" x 9.0"