Quality Risk Management in the FDA-Regulated Industry

Jose (Pepe) Rodriguez-Perez

• Publisher: ASQ Quality Press
• Year: 2024
• Print ISBN:
  9781636941554
• Edition: 3
• eBook ISBN:
  9781636941578
• Topic: Business
• Subtopic: Operations
• Index: Business

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 patients and consumers are placed in jeopardy. In this third edition of Quality Risk Management in the FDA-Regulated Industry, Jose Rodriguez-Perez provides an updated view of the risk management field as it applies to FDA-regulated products using risk-based thinking.

Table of contents

• Quality Risk Management in the FDA-Regulated Industry
• Table of Contents
• List of Figures and Tables
• Acronyms
• Preface to the Third Edition
• Acknowledgments
• Chapter 1 Introduction to Quality Risk Management
• Chapter 2 Current Initiatives
• Chapter 3 Principles of Quality Risk Management
• Chapter 4 General Quality Risk Management Process
• Chapter 5 Integration of Risk Management with Quality Management
• Chapter 6 Methodologies and Tools
• Chapter 7 Practical Applications of Quality Risk Management to the Life Science Manufacturing Industry
• Chapter 8 Risk Management Is More Than FMEA
• Appendix A General Examples
• Appendix B Quality Risk Management Case Study
• Appendix C Fail-Safe FMEA
• Appendix D Quality Risk Management Procedure Model
• Appendix E Useful Websites
• Glossary
• Bibliography