HOW TO DESIGN A WORLD-CLASS Corrective Action Preventive Action SYSTEM FOR FDA-REGULATED INDUSTRIES
A HANDBOOK FOR QUALITY ENGINEERS AND QUALITY MANAGERS
by
$38.00
Book Details
About the Book
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.
About the Author
Mister Muchemu has a degree in Biology and chemistry from
· Johnson and Johnson
·
· American Red cross Biomedical services
· Tissue Banks international
· Abbott laboratories
· Applied Biosystems
and Advanced Bionics