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AM23-MN-02-O - 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)
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.
Learning Objectives:
Define FDA’s Office of Biological Products Operations (OBPO) organizational structure, role in regulatory inspections, and current regulatory oversight.
Discuss the top regulatory violations that are most cited for biological products, including blood, blood components, and cellular therapies.
Describe FDA compliance trends and actions related to biological products, including blood, blood components, and cellular therapies.
Moderator(s):
Susan
Turcovski,
Deputy Director,
FDA Office of Regulatory Affairs Office of Biological Prdts Operations