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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 cell, tissue, and cellular and tissue-based products companies which must comply with CGTP.
In this 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 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.
Upon completion of this course, you will be able to:
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This course is intended for anyone who works for registered human cell, tissue, and cellular and tissue-based product (HCT/Ps) establishments that must comply with CGTP regulations.
It is especially valuable to:
• Executive Directors and CEOs
• Recovery Personnel
• MDs and Medical Directors
• Q/A Managers and Personnel
• Legal Representation
• Donor Screeners
• Laboratory Supervisors and Personnel
• Processing Managers
• Regulatory Managers and Personnel
This training will benefit any individual, partnership, corporation, association, or other legal entity engaged in the manufacture of HCT/Ps, and facilities that engage in contract manufacturing services for a manufacturer of HCT/Ps
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.Learn more
We’ve rebranded! CfPA is now COBBLESTONE