HOW TO DESIGN A WORLD-CLASS Corrective Action Preventive Action SYSTEM FOR FDA-REGULATED INDUSTRIES: A HANDBOOK FOR QUALITY ENGINEERS AND QUALITY MANA

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.