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Educational Session

Quality

BPDR Demystified: A Practical Guide to Reporting & Preventing Errors

AM25-TU-11-L - BPDR Demystified: A Practical Guide to Reporting and Preventing Errors

Tuesday, October 28, 2025
9:30 AM - 11:00 AM  PT
Location: 30CDE
Proposed Session Description: Navigating FDA Biological Product Deviation Reporting (BPDR) can feel overwhelming—but understanding what, when, how, and why to report is crucial for ensuring compliance and patient safety. In this session, we break down BPDR in a practical and engaging way, giving you the confidence to accurately report deviations while avoiding unnecessary submissions.
Through real-world case scenarios, we’ll explore the key reporting requirements, common pitfalls, and how to determine when reporting is (or isn’t) necessary. By the end of this session, you’ll be equipped with the knowledge and tools needed to streamline your reporting process, meet FDA requirements, and strengthen quality assurance in blood, cellular therapy, and biotherapy services. Stay ahead of regulatory challenges and improve reporting accuracy! Join us for this essential session to ensure your organization meets FDA standards while enhancing efficiency and patient safety.

Learning Objectives:

  • Describe the fundamentals of BPDR and why it matters.
  • Identify what, when, how, why, where, and who should report deviations for blood and blood product and cellular therapy related events.
  • Clarify what situations do not require reporting.
  • Navigate FDA BPDR requirements with confidence.
  • Apply your knowledge with interactive case scenarios.