Managing Your FDA Inspection: Before, During and After (San Francisco, CA - June 28-29, 2018) - ResearchAndMarkets.com

Published: Apr 13, 2018

FDA inspects many different kinds of firms. If the FDA regulates your product, they can show up at your lobby and say, I am here to conduct an inspection. What do you do? What have you done to prepare for an inspection? How do you deal with the investigator, including their personality?

Seminar Instructor Casper Uldriks is an "Ex-FDA Official" who has spent 32 years in FDA. He currently trains FDA personnel and counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to the FDA's requirements.

The course will cover the factors used by the FDA to schedule inspections. You will learn how to predict what an FDA investigator will do and what they will cover in the inspection. There should be no surprises if you have prepared properly. Firms need to understand the details about inspectional techniques to avoid making new problems for yourself during the inspection. You can save yourself a lot of corporate misery if you know what to do before, during and after an inspection.

Who will Benefit:

  • Regulatory Affairs Directors
  • Quality Assurance Managers
  • Quality Control Managers
  • Manufacturing Directors and Managers
  • Product Risk Managers
  • Venture Capitalists

Agenda:

1. FDA Legal Authority

2. FDA inspection plans and risk

3. Preparing for an inspection

4. FDA Inspection Procedures

5. FDA staff guidance

6. FDA staff training

7. Inspection strategy and technique

8. War rooms

9. Documenting violations

10. Collecting samples

11. Responding to inspectional observation

12. Responding to a Warning Letter

13. Legal enforcement actions

14. Recall actions and procedures

15. The field District Office

16. The Center(s)

17. The recalling firm

18. Notifying the public

19. Follow up inspections

20. Corrective and Preventive Actions

21. Foreign inspections

22. Import Alert

For more information about this conference visit https://www.researchandmarkets.com/research/wvm3rh/_managing_your?w=4.

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