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CBER's Direct Recall Classification (DRC) Program
Program Code: 094605 Wednesday, July 15, 2009
2:00 PM to 3:30 PM (ET)
MODERATOR Laura Hieronymus , MS, MT(ASCP)SBB, U.S. Food and Drug Administration
SPEAKERS Laura Hieronymus , MS, MT(ASCP)SBB, U.S. Food and Drug Administration Sharon O'Callaghan, MT(ASCP), FDA/CBER
DESCRIPTION
CBER's Direct Recall Classification (DRC) program now provides blood establishments the opportunity to electronically submit recall information to CBER. Following CBER's review of a firm's electronic BPD report, those submitters of BPD reports identified for recall classification will be contacted through e-mail by CBER_RecallAlerts. Attendees of this program will review how to log into CBER On-Line, identify their BPD Additional Information (AI) report, and complete four screens of information required for recall classification purposes.
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