How To Design A World-class Corrective Action Preventive Action System For Fda-regulated Industries: A Handbook For Quality Engine
by David N. Muchemu
2021-01-07 13:56:09
How To Design A World-class Corrective Action Preventive Action System For Fda-regulated Industries: A Handbook For Quality Engine
by David N. Muchemu
2021-01-07 13:56:09
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 ...
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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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