How To Design A World-Class Corrective Action Preventive Action System For Fda-Regulated Industries: A Handbook For Quality Engineers And Quality Managers
- Publish Date: 2006-08-21
- Binding: Paperback
- Author: David Muchemu
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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.
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