Practical Process Validation

Mark Allen Durivage

ISBN 10: 0873899369 / ISBN 13: 9780873899369

Published by ASQ Quality Press, 2016

About this Item

nach der Bestellung gedruckt Neuware - Printed after ordering - 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.

Seller Inventory # 9780873899369

Bibliographic Details

• Title: Practical Process Validation
• Publisher: ASQ Quality Press
• Publication Date: 2016
• Language: English
• ISBN 10: 0873899369
• ISBN 13: 9780873899369
• Binding: Buch
• Condition: Neu
• Dimensions: 260W x 183H x 13D millimeters 260 millimeters width by 183 millimeters height by 13 millimeters depth
• Weight: 509 grams

About this title

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.