Supplier Control - Medical Devices

Training Benefits will include:


1. Understanding the FDA requirements for Supplier Control

2. Should your vendors be registered with FDA?

3. Could they be inspected by FDA?

4. Managing Business and Compliance Risk in the Supply Chain

5. Supplier Qualification

6. Contracts / Agreements

7. First article inspections

8. Placing responsibility where it must be - at the supplier

9. Supplier Auditing Techniques

10. How to close audit observations - from a distance

11. Who to audit and how often

12. Monitoring and Measurement Systems

13. Approved Component Source Control


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. 

Who should attend?

Personnel in Quality, Design, Regulatory, Engineering and Operations in the medical device industry who are responsible for managing, implementing and using Medical Device Systems which are subject to Purchasing Control requirements.


Contact Details

Incra Med LTD,
Unit 204 Business Innovation Centre,
NUI Galway,
Upper Newcastle,
Galway, Ireland.
Phone: 087 2823571