FDA QSRs - The Food and Drug Administration. Quality System Regulations - 21 CFR Part 820

Training Benefits will include:


1. The FDA Quality System Regulations - 21 CFR Part 820. What is it and how to implement it 

2. Developing the Quality System Structures

3. Educating your organisation - Getting the "culture" right

4. Understanding the consequences of inadequate systems

5. Planning and executing efficient FDA oriented internal audits

6. How to bring real business value to the audit process

7. Identifying the weakest links in your design, manufacturing and supply chain

8. Issues - ranking and how to take action

9. Linking identified issues to the CAPA system

10. Keeping management informed

11. The FDA inspection - what to expect and how to prepare

12. The Quality System Inspection Technique - How the FDA propose to review your system

13. Practical preperation workshops

14. First hand knowledge of the FDA Ivestigator approaches


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, Engineering, Operations, Purchasing and Suppliers to the medical device industry who are responsible for managing, implementing and using CAPA systems.


Contact Details

Incra Med LTD,
Unit 204 Business Innovation Centre,
NUI Galway,
Upper Newcastle,
Galway, Ireland.
Email: info@incramed.com
Phone: 087 2823571