Course Description:
FDA's findings of Medical Device company Quality System Regulation (QSR) deficiencies in 2012 fall into four areas, of which two are especially prominent: Corrective and Preventive Action (CAPA) and Production and Process Controls (P&PC), both of which accounted for 30% of all cited deficiencies. Between January 2012 and May 2013, FDA issued 126 Medical Device Warning Letters containing noted CAPA deficiencies.
FDA's findings of Medical Device company Quality System Regulation (QSR) deficiencies in 2012 fall into four areas, of which two are especially prominent: Corrective and Preventive Action (CAPA) and Production and Process Controls (P&PC), both of which accounted for 30% of all cited deficiencies. Between January 2012 and May 2013, FDA issued 126 Medical Device Warning Letters containing noted CAPA deficiencies.
