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.

Erica Swenson DO

Assistant Professor, University of Utah

Appearances