CHANGE CONTROL FOR FDA REGULATED INDUSTRIES: A RISK ASSESMENT APPROACH

by David N. Muchemu

"Next to CAPA,change control is the most audited Quality subsystem by FDA inspectors.Failure to have a robust change control system exposes the organization to regulatory compliance risk,it encourages waste of company resources,and increases the cost of doing business due to waste. This book accomplishes the following for the
.It addresses requirements for Pharmaceutical,Medical Device,Biologics,and Tissue banking change control
.It defines the different phases of the change control life cycle
.It establishes the relationship between risk management,cost of doing business and change control
.It defines regulatory requirements for change control,including requirements for (510k) submission
.It provides tools for risk assessment,and cost/benefit analysis
.It helps the reader design a centralized Change control system that meets and exceeds cGMP requirements"

148 pages, Kindle Edition

First published October 10, 2007