Reviews for CAPA for the FDA-Regulated Industry

Book News Reviews
The CAPA (corrective and preventive action) system is the means by which medical device, biopharmaceutical, and drug manufacturing companies deal with and seek to prevent problem incidents and inadequate CAPA systems are the reasons for most of the regulatory actions taken by the Food and Drug Administration. This text provides guidance to engineers, scientists, and manufacturing and quality personnel across the life sciences industries on understanding, developing, implementing, documenting, and improving a CAPA system and includes forms that can be used as templates for failure investigations, development of corrective and preventive actions, and evaluations of effectiveness. Annotation ©2011 Book News, Inc., Portland, OR (