1. Understanding the FDA and ISO 13485 regulations for CAPA
2. Strategies for enlisting support
3. Improving customer service
4. Responsibility and ownershop sharing
5. Identifying key CAPA performance indicators
6. Risk Management - Seperating the trivial many from the vital few
7. Integrating best practice problem solving
8. Root cause techniques
9. Efficient problem solving for teams
10. CAPA in action - practical exercises
11. Complaint Management
12. Improving timeliness trends
13. The FDA Inspection - what to expect
14. Facilitating an action plan for attendee
Every participant will have the opportunity to identify key requirements in advance of the course.
Free follow up consultation will be available post training from your course tutor.
Personnel in Quality, Engineering, Operations, Purchasing and Suppliers to the medical device industry who are responsible for managing, implementing and using CAPA systems.
Incra Med Ltd.,
Unit 204 Business Innovation Centre,
NUI Galway,
Upper Newcastle,
Galway, Ireland.
Email: info@incramed.com
Phone: 087 2823571
(c) 2020 Incra Med Medical Device Solutions