Practical Process Validation

Mark Allen Durivage, Bob (Bhavan) Mehta

• Publisher: ASQ Quality Press
• Year: 2016
• Print ISBN: 9780873899369
• eBook ISBN: 9781636941028
• Topic: Business
• Subtopic: Auditing
• Index: Business

For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards.The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.

Table of contents

• Practical Process Validation
• Practical Process Validation
• List of Figures and Tables
• Preface
• Acknowledgments
• Limit of Liability/Disclaimer of Warranty
• Chapter 1: Introduction
• Chapter 2: Regulatory and Certification Requirements
• Chapter 3: Establishing Policies and Procedures
• Chapter 4: Validation Prerequisites
• Chapter 5: Process Validation Considerations
• Chapter 6: Validation Master Plan
• Chapter 7: Software Validation
• Chapter 8: Revalidation and Retrospective Validation
• Chapter 9: Sample Size Considerations
• Chapter 10: Control Charts for Continuous Process Monitoring
• Chapter 11: Outliers
• Chapter 12: Process Capability
• Chapter 13: Common Validation Issues
• Appendix A: Distribution of the Chi-Square
• Appendix B: Control Chart Constants
• Appendix C: Critical Values of the Dean and Dixon Outlier Test
• Appendix D: Critical Values for the Grubbs Outlier Test
• Glossary
• Bibliography