Quality System Inspection Technique (QSIT) :FDA

June 18, 2009

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

  1. CAPA – The Heart of Your Quality System
  2. CAPA systems in Post Marketing Surveillance
  3. Root Cause Analysis for CAPA Management (Shutting Down the Alligator Farm
  4. How CAPA and complaint handling should interact in Medical Device – Simplification of the processes is often needed to preserve their effectiveness
  5. Preparation of a corrective action/preventive action plan (CAPA) in Drug Safety/Pharmacovigilanc