HOW TO DESIGN A WORLD-CLASS Corrective Action Preventive Action SYSTEM FOR FDA-REGULATED INDUSTRIES: A Handbook for Quality Engineers and Quality Mana

By David N. Muchemu

Book Overview

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.

• Format: Paperback
• Language: English
• ISBN: 1425950531
• ISBN13: 9781425950538
• Release Date: August 2006
• Publisher: Authorhouse
• Length: 104 Pages
• Weight: 0.65 lbs.
• Dimensions: 0.2" x 8.3" x 11.0"