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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


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.  Read more...

 
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More About How to Design a World-Class Corrective Action Preventive Action System for FDA-Regulated Industries by David N. Muchemu
 
 
 
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.

 
Details
  • ISBN-13: 9781425950538
  • ISBN-10: 1425950531
  • Publisher: Authorhouse
  • Publish Date: August 2006
  • Page Count: 104
  • Dimensions: 11 x 8.25 x 0.22 inches
  • Shipping Weight: 0.56 pounds


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