Risk Management Approach for Cell Therapeutics with Case Studies
Sponsored by the ISCT North American Legal and Regulatory Affairs Committee
- Asiya Imam, PhD, CQA Senior Manager, Quality System / Advanced Bioprocessing BD Biosciences
- Olive Sturtevant, MHP, MT(ASCP) SBB/SLS, Quality Assurance Manager, Dana-Farber Cancer Institute
- Utilizing tools of risk management from the device world and using them to develop an approach for cellular therapeutic products
- Root cause analysis
- Prospective risk assessment for program planning
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.