Ready for FDA?

Training Benefits will include:


1. First hand information on FDA inspection experiences

2. 21 CFR Part 820 - implementing all of the requirements into your system

3. Key issues everyone in the organisation should know

4. A system V's records focused inspection

5. The Quality System Inspection Technique - QSIT

6. How to evaluate your overall state of compliance

7.Closing the gaps

8. The Team Factor

9. Project Management of preperations

10. Consequences of a poor inspection result

11. Identifying appropriate Front-Line personnel for the inspection

12. During the audit - key watchouts

13. The format of the 483 observation

14. The FDA warning letter

15. Responding to observations


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 Suppliers to the medical device industry who are responsible for managing, implementing and using Medical Device Systems which may be subject to FDA inspection.


Contact Details

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