October 15, 2009 - Interpretation of the Final Rule: cGMP and Investigational New Drugs Intended for Use in Phase 1 Clinical Trials
- CGMP for Phase 1 INDs: Manufacturing Cell Therapy Products | Scott Burger, MD
- CGMP for Phase 1 INDs | Laurie P. Norwood, MS
- Web Seminar Handouts
- Web Seminar Audio File
July 16, 2009 - Deviation Management of Type 351 and 361 Cell Products
- Reporting Deviations of Biological Products and HCT/Ps | Ellen Areman
- Web Seminar Handouts
- Question & Answer Session Transcription
- Web Seminar Audio File
January 29, 2009 - Qualification: Vendor, Equipment and Supplies
- Vendor Qualification | Fran Rabe, BA
- Equipment Qualification | Adrian P. Gee, MI Biol., PhD
- Supply Qualification | Chris Chun, MT (ASCP) HP
- Web Seminar Handouts
- Question & Answer Session Transcription
- Web Seminar Audio File
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