Please note: AABB reserves the right to make updates to this program.
Live Program Date: Wednesday, June 6, 2018 -
Master Program Number: 18EL-337 (see program format numbers below under Registration)
Educational Track: Quality Education
Topic: Transfusion Medicine
Intended Audience: CEOs, CFOs, COOs, Director, Facilities that perform molecular testing, Hospitals, Hospital Blood Banks, Immunohematology Reference Labs (IRL’s), Laboratory Staff, Managers/Supervisors, Medical Directors, Nurses, Perfusionists, Physicians, Research Scientist, Resident/Fellow, Scientists, Students (MD, MT, SBB), Technologists, Transfusion Safety Officer
Teaching Level: Basic to Intermediate
Director/Moderator: Angela Dirr, Senior Director, Blood Care, Bonfils Blood Center, United Blood Services, Denver, CO
Speaker: Gina Ramirez, MT(ASCP), CQA, RAC, Regulatory Manager, Blood Systems Inc., Denver, CO
Presentation was prepared by Gina Ramirez and Mark Georgescu, Regulatory Manager, Blood Systems, Inc., Phoenix, AZ and presented by Gina Ramirez.
After participating in this educational activity, participants should be able to:
- Gain understanding of the FDA Guidance on Reporting Biological Product Deviations.
- Determine if a deviation is reportable or non-reportable.
- Learn coding and classification of BPDs.
- Review recent BPD data released by FDA.
By the end of the program the participants will be able to define and understand what a biological deviation means within the transfusion medicine environment. The 60-minute presentation will focus on how to determine if a BPD as reportable or non-reportable. Coding and classification of BPDs also be discussed in detail. Ask the subject matter experts your questions and learn from the experts how to problem solve your BPD concerns.
| || ||
|Single Viewer: On-Demand||
|Group Viewing: On-Demand||
Mark Georgescu &
Gina Ramirez, MT(ASCP), CQA, RAC. Together Gina and Mark offer decades of regulatory and compliance expertise and leadership in all aspects of transfusion medicine. These experts have completed countless FDA submission, validation protocols and BPDs to give a small snapshot of their work expertise and experience. Gina and Mark are well-versed in a variety of transfusion and blood banking regulatory agencies such as the FDA, AABB and CLIAA to name a few.