HOW TO DESIGN A WORLD-CLASS Corrective Action Preventive Action SYSTEM FOR FDA-REGULATED INDUSTRIES: A Handbook for Quality Engineers and Quality Mana

ISBN-13: 9781425950538 / Angielski / Miękka / 2006 / 104 str.

David N. Muchemu

Opis

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.