HOW TO DESIGN A WORLD-CLASS Corrective Action Preventive Action SYSTEM FOR FDA-REGULATED INDUSTRIES: A HANDBOOK FOR QUALITY ENGINEERS AND QUALITY MANAGERS

Muchemu, David

ISBN 10: 1425950531 / ISBN 13: 9781425950538

Published by AuthorHouse, 2006

This softcover has a tight spine without reading crease. Covers clean and crisp. Pages appear bright and unmarked. We ship FAST! Seller Inventory # 2403200002

Synopsis:

The CAPA (Corrective Action/Preventive Action) Quality subsystem is the most audited by FDA inspectors. This book is designed to help Quality management professionals in Biomedical, Pharmaceutical, Tissue, and Medical Device industries design a CAPA Quality subsystem that meets and exceeds CAPA requirements in 21CFR 820.100(J).This book accomplishes the following:· Defines CAPA· Provides cross-functional process flows· Provides requirements for a CAPA system· Provides examples for the document hierarchy needed· Provides definitions for a CAPA system· Provides examples of work instructions, and standard operating procedures for a CAPA system.

Product Description: The CAPA (Corrective Action/Preventive Action) Quality subsystem is the most audited by FDA inspectors. This book is designed to help Quality management professionals in Biomedical, Pharmaceutical, Tissue, and Medical Device industries design a CAPA Quality subsystem that meets and exceeds CAPA requirements in 21CFR 820.100(J).This book accomplishes the following:· Defines CAPA· Provides cross-functional process flows· Provides requirements for a CAPA system· Provides examples for the document hierarchy needed· Provides definitions for a CAPA system· Provides examples of work instructions, and standard operating procedures for a CAPA system.

Bibliographic Details

Title: HOW TO DESIGN A WORLD-CLASS Corrective ...
Publisher: AuthorHouse
Publication Date: 2006
Binding: paperback
Condition: Very Good