HOW TO DESIGN A WORLD-CLASS Corrective Action Preventive Action SYSTEM FOR FDA-REGULATED INDUSTRIES

HOW TO DESIGN A WORLD-CLASS Corrective Action Preventive Action SYSTEM FOR FDA-REGULATED INDUSTRIES

HOW TO DESIGN A WORLD-CLASS Corrective Action Preventive Action SYSTEM FOR FDA-REGULATED INDUSTRIES

David N. Muchemu / DAVID NMUCHEMU

43,41 €
IVA incluido
Disponible
Editorial:
AuthorHouse
Año de edición:
2006
ISBN:
9781425950538
43,41 €
IVA incluido
Disponible

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Sobre IBD

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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