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ISCT Webinar: Validation of Processes - Mar 25 2009

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(Part 2): Validation of Processes: Retrospective and Prospective


Sponsored by the ISCT Lab Practices Committee


  • Elizabeth Konecki, MS, MT(ASCP), SBB, Wilford Hall Medical Center
  • Olive Sturtevant, MHP, MT(ASCP) SBB/SLS, Quality Assurance Manager, Dana-Farber Cancer Institute


  1. Outline the components of process validation.
  2. Apply the components of validation to prospective and retrospective processes.
    • Include specific examples of process validation for cellular therapy applications.
  3. Address how to determine the appropriate or significant number of validation trials for a given process.
    • Discuss challenges presented by staffing/smaller laboratories.
    • Discuss how to handle validation failures or non-conforming products for "re-validation”.


This product is a downloadable zipped folder containing an mp3 audio recording of the presentation and a PDF copy (or copies) of the Power Point slides. 


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