Quality Risk Management in the FDA-Regulated Industry, Third Edition

For quality professionals and manufacturers in the food safety and medical device industries, risk management is essential to ensuring organizations meet FDA regulations and requirements. Without these recognized standards, the lives of consumers are placed in jeopardy. In this third edition of Quality Risk Management in the FDA-Regulated Industry, the author provides an updated view of the risk management field as it applies to FDA-regulated products using risk-based thinking.

Updates to this edition address:

• How to integrate risk management principles and activities into an existing quality management system (QMS)
• Compliance with current ISO Standards 9001:2015 and ISO 13485:2016
• Discussion of three key and recently updated guidelines: ICH Q9(R1), ISO 14971:2019, and ISO 22000:2018

José (Pepe) Rodríguez-Pérez, Ph.D., CSSBB, CMQ/OE, CQE, CQA, CFSQA, CMDA, and CPGP, is president of Business Excellence Consulting Inc. (BEC), a Puerto Rico-based consulting, training, and remediation firm that focuses on the areas of regulatory compliance, FDA-regulatory training, and risk management. Over his career, he has served as an educator, technical services manager, and as a science advisor to the FDA. He is also the author of several best-selling books including the Handbook of Investigation and Effective CAPA Systems, Third Edition, and Human Error Reduction in Manufacturing, Second Edition, both published by Quality Press.