Process Validation 101 (21EL-608)

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

Wednesday, February 24, 2021
2:00 – 3:00 PM Eastern Time
Program Number: 21EL-608

  • Educational Track: Quality Education
  • Topics: Accreditation, Cellular Therapy, Management Operations, Operations, Patient Transfusion, Processing, Quality, Quality Systems, Standards
  • Intended Audience: Hospital Blood Banks, Laboratory Staff, Managers/Supervisors, Medical Directors, Quality Unit Personnel, Residents/Fellows, Students (MD, MT, SBB), Technologists, Transfusion Safety Officers
  • Teaching Level: Basic
  • Director/Moderator: Leane Ziebell, MSA, MT(ASCP)SBB, CQA(ASQ), Senior Director, Quality, American Red Cross, Washington, DC
    Speaker: Michele Herman, MT(ASCP), Compliance Officer, Transfusion Medicine, Beth Israel Deaconess Medical Center, Boston, MA

  • Program Description

    This program is intended to provide an introductory or refresher training of validation of manufacturing processes. It will provide a broad overview of the validation process, focusing on end user validation. Validation examples and templates will be discussed based on the experience of a hospital-based blood bank and cellular therapy facility.

    Learning Objectives

    After participating in this educational activity, participants should be able to:

    • Identify the goals of process validation.
    • Discuss role of risk assessment in validation.
    • Discuss key elements of process validation.


    Registration includes access to both the live and on-demand version of this eCast.

    AABB understands the value of learning together as a group but with COVID-19, bringing everyone together to share the experience in person may not be an option for your team. Given this, all participants in a group will be provided the ability to register as a single viewer (AABB will provide a promocode to registered group viewing coordinators to share with their team in advance of the live program). If you are a facility interested in participating in this eCast, simply complete the Group Viewing registration form and AABB will provide detailed instructions to share with your team. For single viewers, the process has not changed – simply click on the Register button below to register.

    Please note: registration for the live eCast will close 1 hour prior to the eCast start time. If you register after this time you will receive access to the on-demand eCast when it is available.

    Single Viewer Register
    Group Viewing Register

    Continuing Education Credit

    AABB estimates both the live and on-demand version of this eCast each to be eligible for 1 continuing education credits/contact hours for Physicians, California Nurse, California Lab Personnel, Florida Lab Personnel and General Participation credit. The final number of credit(s) and credit types awarded for this program (live or on-demand) will be determined by the program duration. For more information on each credit type please visit our Continuing Education Credits webpage.

    Disclosures for the planners of this event can be found here. Disclosures for the program faculty are provided at the beginning of the program.

    Speaker Biography

    Michele Herman is a compliance officer for the pathology department of Beth Israel Deaconess Medical Center, Boston, Massachusetts. She currently manages the quality programs for the blood bank transfusion service and hematopoietic cellular therapy processing and managed the quality program for an investigational cellular therapy product for many years. Her past experience also includes blood donor room collection, blood component processing and related quality activities.