Practical Process Validation

Mark Allen Durivage; Bob (Bhavan) Mehta

ISBN 10: 0873899369 / ISBN 13: 9780873899369

Published by ASQ Quality Press, 2016

Pages are clean with no markings. May show minor signs of wear or cosmetic defects marks, cuts, bends, or scuffs on the cover, spine, pages, or dust jacket. May have remainder marks on edges. Seller Inventory # DBV.0873899369.VG

Synopsis:

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.

Bibliographic Details

Title: Practical Process Validation
Publisher: ASQ Quality Press
Publication Date: 2016
Binding: Hardcover
Condition: very_good