Course Syllabus

Cell Product Handling & Regulatory 101 

Session 1: Collections

Speaker: Federico Rodriguez Quezada, SBB, MLS (ASCP)

UF Health Shands BMT Program

  • Cell sources and how they are collected (apheresis, bone marrow, cord blood)
  • Comparison of the different cell sources (apheresis vs bone marrow vs cord blood)
  • Types of donors (haploidentical, matched related, matched unrelated)
  • Donor suitability and eligibility

Session 2: Processing and QC

Speaker: Darin Sumstad, MLS (ASCP)

Health Fairview University of Minnesota Medical Center

  • Basic processing techniques
  • Manual vs automated systems
  • Fundamentals & advances in processing and manufacturing – the example of RBC reduction

Session 3: Quality Assurance/Regulatory

Speaker: Wade Atkins, MS, MT (ASCP), SBB, CQA (ASQ)

NIH Clinical Center Department of Transfusion Medicine (DTM)

  • Operational GTPs
  • Nonconformities & deviations: communication & roles
  • Product release

Session 4: Product Storage, Distribution & Logistics

    Speaker: Ljiljana Vasovic, MD

    Weill Cornell Medicine

    • Scheduling, orders & communication
    • Shipping vs transportation
    • Equipment associated with storage and distribution
    • Thawing, tracking