Recent FDA enforcement trends (including 2013) reveal that both design control and Corrective and Preventive Action (CAPA) systems are critical elements to sustain FDA inspections.
Device manufacturers are required to establish and maintain FDA-compliant quality management systems, where appropriate and applicable, including design control and CAPA systems. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control and CAPA system requirements. This presentation is further intended to help you establish and maintain adequate design control and CAPA procedures for all classes of medical devices including IVDs.
Device manufacturers are required to establish and maintain FDA-compliant quality management systems, where appropriate and applicable, including design control and CAPA systems. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control and CAPA system requirements. This presentation is further intended to help you establish and maintain adequate design control and CAPA procedures for all classes of medical devices including IVDs.
