A Two-day interactive Workshop and Case Study Sessions on:
Regulatory Requirements for CAPAs
The importance of a Process Improvement Team in a strong CAPA program
Global Harmonization Task Force- SG3
Common misconceptions about CAPAs
Developing and Implementing an Effective CAPA Program
Auditing the Failure or Process Deviation Investigation (Workshop)
Determine Significance of Product Issues: Corrective or Preventive (Exercise)
Handling OOS Results and Laboratory Failures
CAPA Trends and Practices- From Initiation to Closure
How FDA Trains its Inspectors to Review CAPA, and Recommended Compliance Methods- (Workshop)
Beyond Procedures and Checklists – Organizational Practices that impact CAPA Effectiveness