ABC's of BPDs

Please note: AABB reserves the right to make updates to this program.

Wednesday, June 6, 2018
2:00 – 3:00 PM (ET) 7:00 – 8:00 PM (GMT)
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
Speakers: Mark Georgescu, Regulatory Manager, Blood Systems, Inc., Phoenix, AZ; Gina Ramirez, MT(ASCP), CQA, RAC, Regulatory Manager, Blood Systems Inc., Denver, CO

Learning Objectives

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.

Program Description

Registration

   Program #
Single Viewer: Live Register18EL-3-2035
Single Viewer: On-Demand Register18EL-3-4035
Group Viewing: Live Register18EL-3-6035
Group Viewing: On-Demand Register18EL-3-8035
Group Viewing: Live & On-Demand Register18EL-3-9935

Speaker Biographies

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.