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AM24-TU-10-O
AM24-TU-10-O: Is Your Firm Ready for an FDA Office of Inspections and Investigations Inspection? Hear about the Most Frequently Cited Observations and Inspectional Process from FDA’s Office of Biologics Inspectorate (Enduring)
Date
October 23, 2024
Credits
1 General Continuing Education (GEN) | 1 Florida Lab Personnel (FLP) | 1 California Nurse (CN) | 1 California Lab Personnel (CLP) | 1 Physician (PHY)
$30
Standard Price
Members save $5
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Interested in all sessions Cellular Therapy/Biotherapies? Then this is the package for you. We have also thrown in a couple of additional sessions you might also find interesting…
Interested in sessions eligible to maintain your AABB Certified Advanced Biotherapies Professional (CABP) certification? This package provides:
By far the best value to watch all the on-demand educational sessions from the 2024 AABB Annual Meeting and earn continuing education credit…
CABP CE Eligible
This informative session will give an overview of inspections conducted by FDA’s Office of Inspections and Investigations (OII), Office of Biologics Inspectorate (OBI), including OBI’s role in regulatory inspections and current regulatory oversight. We will discuss the top FDA regulatory violations that are most cited for biological products, including blood, blood components, and cellular therapies, along with example FDA-483 observations and best practices to avoid being cited for these deficiencies. We will also review what to expect before, during, and after an inspection.
Learning Objectives
- Define FDA’s Office of Biological Products Operations (OBPO) organizational structure, role in regulatory inspections, and current regulatory oversight.
- Discuss the top FDA regulatory violations that are most cited for biological products, including blood, blood components, and cellular therapies.
- Describe what to expect before, during, and after an FDA inspection.
Moderator
Speakers
Biologics National Expert Investigator, US Food and Drug Administration
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