Topics
- The difference between corrective action, correction and preventive action and why they are different
- Tools and methods to create an integrated CAPA system
- Common problem solving and improvement methodologies, quality tools and their application to the CAPA system
- Medical device CAPA regulatory requirements including FDA QSR and ISO 13485
- The linkages between complaints, corrective action, and risk management
- "appropriate statistical methodology" to analyze data and existing and potential causes of quality problems
- Regulatory requirements for corrective actions in the field for both the US and the EU
Who should Attend
Attendees from medical device companies, including Quality Engineers, Quality Managers, Operations Managers, Regulatory professionals, Risk Managers, Manufacturing Engineers, CAPA team members and Complaint system team members.
