This session will be presented by the FDA’s Office of Regulatory Affairs (ORA), Office of Biological Products Operations (OBPO). The discussion will include the organizational structure of OBPO, including OBPO’s role in regulatory inspections and current regulatory oversight. The top regulatory violations that are most cited, compliance trends, and actions for biological products, including blood, blood components, and cellular therapies, will be discussed.
All relevant financial relationships have been mitigated.
By completing the evaluation, you are attesting to watching the presentation in its entirety. A certificate will be immediately provided after submission.
AM23-MN-02-O: Inspection Findings and Updates from FDA’s Office of Regulatory Affairs - Where Does Your Institution Rank Regarding the Most Cited Deficiencies? (Enduring) Evaluation