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2022 AABB Annual Meeting

AM22-ST07-E - AM22-ST07-E: (On-Demand) Inspection Findings and Compliance Updates from FDA’s Office of Regulatory Affairs Inspectorate – Where Does Your Firm Rank Regarding the Most Cited Deficiencies on FDA-483s? (Enduring)


Oct 4, 2022 12:00pm ‐ Oct 4, 2022 1:00pm



Credits: None available.

Description

This session will be presented by FDA’s Office of Regulatory Affairs (ORA), Office of Biological Products Operations (OBPO). 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 along with 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.

Speaker(s):

Moderator(s):

Disclosures

  • Samantha Pinizzotto, DVM : Nothing to Disclose
  • Susan Turcovski : Nothing to Disclose
  • Scott Ballard : Nothing to Disclose

Credits

Credits: None available.

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