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:· 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.