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Book Cover for: HOW TO DESIGN A WORLD-CLASS Corrective Action Preventive Action SYSTEM FOR FDA-REGULATED INDUSTRIES: A Handbook for Quality Engineers and Quality Mana, David N. Muchemu

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

David N. 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: Â- Defines CAPA Â- Provides cross-functional process flows Â- Provides requirements for a CAPA system Â- Provides examples for the document hierarchy needed Â- Provides definitions for a CAPA system Â- Provides examples of work instructions, and standard operating procedures for a CAPA system.

Book Details

  • Publisher: Authorhouse
  • Publish Date: Aug 17th, 2006
  • Pages: 104
  • Language: English
  • Edition: undefined - undefined
  • Dimensions: 11.00in - 8.25in - 0.22in - 0.56lb
  • EAN: 9781425950538