How to Design a World-class Corrective Action Preventive Action System for Fda-regulated Industries A Handbook for Quality Engineers and Quality Managers

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: B7 Defines CAPA B7 Provides cross-functional process flows B7 Provides requirements for a CAPA system B7 Provides examples for the document hierarchy needed B7 Provides definitions for a CAPA system B7 Provides examples of work instructions, and standard operating procedures for a CAPA system.Muchemu, David N. is the author of 'How to Design a World-class Corrective Action Preventive Action System for Fda-regulated Industries A Handbook for Quality Engineers and Quality Managers' with ISBN 9781425950538 and ISBN 1425950531.