Process Validation

Training Benefits will include:


1. Understanding the FDA and ISO 13485 regulations for validation

2. When must validation take place?

3. The Master Validation plan

4. Managing process changes

5. The role of the validation reviewer

6. The differences between verification and validation

7. IQ, OQ, PQ

8. Is your process ready for validation

9. Software Validation methods

10. The cost benefits of validation

11. Did the validation achieve what it was intended to achieve?

12. Validation pitfalls

13. Managing the FDA investigation of validations

14. Facilitating an action plan for attendees


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, Operations and Sub Contractors to the medical device industry who are reponsible for managing, implementing and using Medical Device Manufacturing Systems which may subject to Process Validation requirements.


Contact Details

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