| Cart Total:
Checkout
Dismiss
Menu
Practical Process Validation
Practical Process Validation

Practical Process Validation

Mark Allen Durivage, Bob (Bhavan) Mehta

Hardcover, 168 pages, Published 2016
Dimensions: 7 x 10
ISBN: 9780873899369
Item Number: H1513

Member Price: $49.00

List Price: $70.00
Add To Cart
Interested in purchasing bulk quantities?
View the discounted rates, or contact Customer Care to learn more.

Keywords

  • process validation

Description

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.