Achieving Customer Experience Excellence through a Quality Management System (Hardcover) (ISBN-13: 9780873899352)

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. This book was written to assist quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting process validations that meet regulatory and certification requirements. It provides an introduction and background to the requirements necessary to perform process validations that will comply with regulatory and certification body requirements.

Author: Alka Jarvis, Luis Morales, Ulka Ranadive
ISBN-10: 0873899350
ISBN-13: 9780873899352
Publisher: ASQ Quality Press
Language: English
Published: 07/04/2016
Pages: 182
Format: Hardcover
Weight: 1.18lbs
Size: 10.00h x 7.00w x 0.44d