The Food and Drug Administration (FDA) amended the Current Good Manufacturing Practice (CGMP) regulations requiring all establishments involved in the manufacture of blood and blood components to report product deviations in manufacturing as of May 7, 2001. Fast forward 18 years and uncertainties still exist concerning what type of facilities as well as which deviations must be reported to the FDA
“To Tell the Truth”, a participant favorite, is back to challenge your knowledge of the FDA requirements for Biological Product Deviation Reporting (BPDR). During this session the current reporting requirements will be reviewed. In an interactive format, the 2019 panel of BPDR “experts” will then present scenarios of deviations that have occurred in blood centers, transfusion services and HPC (Hematopoietic Progenitor Cells) facilities and indicate if they believe that particular situation is reportable. Scenarios will incorporate revised criteria for reporting (or not!) that are updated annually in October by the FDA. Attendees will then use an automated feedback response system to vote on which panelist they believe is “Telling the Truth” according to their interpretation of the regulations. Each panelist is a convincing “expert” in FDA reporting, however you get to decide who really the expert is! The “truth” will then be revealed and the rationale for that determination summarized. The opportunity will be provided for participant follow-up or debate. Are you up to the challenge? If so, bring your electronic devices and be prepared to have fun seeing and learning how your thoughts compare to your colleagues and the esteemed panelists!
Identify which facilities are required to report deviations to the FDA.
Summarize criteria for determining what deviations need to be reported.
Differentiate which deviations in manufacturing need to be reported and defend which do not need to be reported to the FDA.
Describe the time frames for reporting as well as how and where to report.