Laura Hieronymus Senior Recall Coordinator, CBER Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research Food and Drug Administration CBER’s Direct Recall Classification Program
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Laura HieronymusSenior Recall Coordinator, CBER
Office of Compliance and Biologics QualityCenter for Biologics Evaluation and Research
Food and Drug Administration
CBER’s Direct Recall Classification
Program
22
Understand CBER’s Direct Recall Classification (DRC) Program.
Learn how to access your establishment’s Additional Information (AI) report through CBER On-Line.
Learn how to submit Additional Information (AI) reports to CBER for recall classification purposes.
Objectives
3
CBER On-Line – Main Menu
3
eBPDR – Reporting Establishment Information
44
eBPDR – Biological Product Deviation (BPD) Information
55
6
eBPDR – Description of Biological Product Deviation
7
eBPDR – Description of Contributing Factors for BPD
8
eBPDR – Description of Follow-Up for BPD
99
eBPDR: Electronic Biological Product Deviation Report - Preview
Page
1010
Electronic Biological Product Deviation Receipt Confirmation
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From: [email protected]: [email protected]; [email protected]: BPD Additional Information (AI)- Conf # 300943, Facility # 1234567890
Thank you for your electronic submission of the Biologic Product Deviation Report (BPDR) or HCT/P Deviation Reportreferenced below. The Center for Biologics Evaluation and Research has completed an initial review of thisBPDR. Additional information is necessary to complete our review for possible recall classificationpurposes.
The web form used to provide CBER this additional information is available athttps://www.accessdata.fda.gov/scripts/cber/CFApps/Login/Index.cfm
Access to the form requires the BPDR submitter's username and password.Upon login, access the electronic BPDR System (eBPDR) and select "Unfinished Reports".
FEI# : 1234567890 BPD Confirmation# : 300943 BPD Submitted Date : 06/28/2013Establishment Tracking# : 0012013 Note: To provide BPD Additional Information (AI) access to multiple authorized representatives, you may create a singleuser account to submit future BPD reports.
Thank You,CBER Recall CoordinatorFood and Drug Administration
BPDR Email Communication
1212
CBER On-Line - Main Menu
1313
eBPDR - Unfinished Reports
1414
BPD AI - Updated Product Disposition
1515
BPD AI - Notification Method
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BPD AI - Distribution Pattern Information
1717
BPD AI - Distribution Pattern Information (cont.)
1818
BPD AI - Industry Recall Contacts
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BPD AI - Industry Recall Contacts (cont.)
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BPD AI - Preview Report
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BPD AI – Preview Report/ Industry Recall Contacts
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BPD AI - Submitted Report
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BPD AI - Submitted Report/Industry Recall Contacts
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www.fda.gov/Safety/Recalls/EnforcementReports/default.htm
Event ID 12345
Product Type Corneas
Status Completed
Recalling Firm Eye Bank, Inc.
City Rockville
State Maryland
Country US
Voluntary/Mandated Voluntary; Firm Initiated
Recall Initiation Date 06-03-2013
Initial Firm Notification Telephone
Distribution Pattern MD, PA
Enforcement Report Event Detail
26http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm
Product Description
Code Information
Classification Reason for Recall
Product Quantity
Recall Number
Corneas Lots 123 & 456
Class II Corneas, recovered from an ineligible donor, were distributed.
2 Corneas
B-0123-13
Enforcement ReportProduct Detail
2727
• Phone: toll-free 1-800-835-4709 (or 301-827-1800)• E-mail: [email protected]• On the web:
http://www.fda.gov/BiologicsBloodVaccines/default.htm• Follow us on Twitter: http://twitter.com/#!/FDACBER
Questions about today’s webinar?
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