(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
- Outline the components of process validation.
- Apply the components of validation to prospective and retrospective processes.
- Include specific examples of process validation for cellular therapy applications.
- 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.