"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 ...
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"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.
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