Practical Process Validation (Hardcover) (ISBN-13: 9780873899369)

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.

Author: Mark Allen Durivage, Bob (Bhavan) Mehta
ISBN-10: 0873899369
ISBN-13: 9780873899369
Publisher: ASQ Quality Press
Language: English
Published: 07/11/2016
Pages: 160
Format: Hardcover
Weight: 1.10lbs
Size: 10.00h x 7.00w x 0.44d