CAPA for the FDA-Regulated Industry

Description

Medical devices, biopharmaceutical, and traditional drug manufacturing companies devote an important part of their resources to dealing with incidents, investigations, and corrective and preventive actions. The corrective and preventive action system is known as the CAPA system. It is second to none in terms of frequency and criticality of its deviations, and most of the regulatory actions taken by the FDA and foreign regulators are linked to inadequate CAPA systems. This guidance book provides useful and up-to-date information about this critical topic to thousands of engineers, scientists, and manufacturing and quality personnel across the life sciences industries.