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Description
This course provides essential training for those working with cellular and tissue-based products in the cell, gene therapy, and biologics industry. It explains the regulatory background of cell therapy products by detailing the U.S. Food and Drug Administration’s (FDA) regulations at 21 CFR 1271. The course describes what current Good Tissue Practices (cGTPs) are and how they apply to donor eligibility, quality programs, and deviation and adverse event reporting.
Audience
Academic Medical Centers, Blood and Tissue Banks, Faculty, Principal Investigators (PIs), Sponsors, Students
