According to the FDA, 30% of the 10 most frequent observations in Form 483s issued for QSIT inspections are related to CAPA, and 50% are CAPA-related for non-QSIT inspections.
See webinars which can help device makers to ensure quality standards
- CAPA – The Heart of Your Quality System
- CAPA systems in Post Marketing Surveillance
- Root Cause Analysis for CAPA Management (Shutting Down the Alligator Farm
- How CAPA and complaint handling should interact in Medical Device – Simplification of the processes is often needed to preserve their effectiveness
- Preparation of a corrective action/preventive action plan (CAPA) in Drug Safety/Pharmacovigilanc