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ISCT Webinar: Conducting Validation Studies for Shipping of Cells

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Description

ISCT Webinar: Conducting Validation Studies for Shipping of Cells

Date: September 7, 2016

Time: 09:00 PT, 12:00 EST, 18:00 CEST

 

Co-Chairs: 

  • Wade Atkins, MS, MT(ASCP)SBB, CQA (ASQ), Quality Assurance Specialist, Department of Transfusion Medicine, National Institutes of Health, USA
  • Aisha Khan, MSc, MBA, Executive Director of Laboratory Operations, Interdisciplinary Stem Cell Institute, University of Miami, USA

Speakers: 

  • Diane Kadidlo, MT(ASCP)SBB, Facility Director, Molecular and Cellular Therapeutics Facility, University of Minnesota, USA
  • Day Longsomboon, MA, Regulatory Manager, Interdisciplinary Stem Cell Institute, University of Miami, USA 

 

Description:

Shipping human cells and tissues is never as easy as it sounds.  While it may seem intuitive about packing the container into a box and adding some ice or dry ice or even room temperature block to a box, there are pitfalls.  This workshop will review the regulatory requirements for shipping biological products.  The speakers will review the principles of validations and how to apply them to a shipping process and to acceptable containers.   Case studies will be presented to illustrate key points along with a short discussion on applying these concepts to international product shipments.

 

Learning Objectives:

· Understand regulatory requirements and principles of the validation of the procedures

· Designing a validation studies for shipping of cells

· Discuss examples of validation case studies

· Considerations for international shipping