DUBLIN--(BUSINESS WIRE)--The "Managing Your FDA Inspection: Before, During and After" conference has been added to ResearchAndMarkets.com's offering.
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
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.