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

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.