An Introduction to Current Good Tissue Practice (GTP)

The US FDA's current Good Tissue Practice regulations constitute a significant compliance challenge for the Human Tissue Industry. This course is intended to provide hands-on training for anyone who works for human cells, tissues, and cellular and tissue-based products companies which must comply with cGTP. In this 90-minute intensive training, we will review the Public Health Service Act (PHS), the federal Food, Drug, and Cosmetic Act (FD&C) and their regulatory authority. Discussion of the regulations and available guidance’s will be covered including Section 351 and 361 products and determination of minimal manipulation. Deep dive into cGTPs, as outlined in Subpart D, including facilities, environmental controls, equipment, supplies and reagents, recovery, processing and process controls, labeling, storage, receipt, pre-distribution shipment, and distribution. The course will provide tips on how to implement these regulations in a practical format. Participants in this course will gain a detailed understanding of what is required to achieve and maintain compliance with these important regulations.