DAVID N. MUCHEMU
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.
Mister Muchemu has a degree in Biology and chemistry from Warren Wilson College in North Carolina. He is an MBA with over twenty years of experience in Medical Device, Biomedical, Tissue banking, and Pharmaceutical organizations. Over the years Mister Muchemu has worked as a Quality Engineer, Quality manager, Supplier Quality Engineer, and Change control manager. His passion is Quality management, and Quality control. Mister Muchemu's career path has taken him through various Quality Control and Quality management positions in the following organizations:
· Johnson and Johnson
· Boston scientific
· American Red cross Biomedical services
· Tissue Banks international
· Abbott laboratories
· Applied Biosystems
and Advanced Bionics
CAPA is a continous process improvement Quality subsystem with two interactive loops: The Reactive loop(After the fact) deals with Corrective Action,and corrections.The Proactive loop(Before the fact) deals with Preventive Action.Events that appear in the corrective loop are sysmptoms of failures in the preventive loop.An effecient CAPA system should always have more Preventive Action Requests(PARs) than Corrective Action Requests(CARs)!
