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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 moreRemember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.
“All organizations that recover, screen, test, process, store, label, pack and/or distribute Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) must adhere to the current Good Tissue Practice regulation (cGTP), 21 CFR Part 1271 Subparts D. Set by US FDA, this regulation can appear to be a confusing collection of legal requirements for the uninitiated.
This accredited 12-hour VIRTUAL ON DEMAND training will remove the confusion and enable participants to fully understand and comply with the requirements of this landmark regulation. The course includes interactive discussion of all the key elements of the cGTPs with an emphasis on real world implementation, illustrated with real life examples. From organization, personnel and facility requirements to process and software validation to complaint handling, records and Part 11 expectations, participants in this course will gain a detailed understanding of what is required to achieve and maintain compliance with this important regulation. A recorded workshop on learning from the mistakes of others is included.”
“The US FDA current Good Tissue Practices Regulation constitutes 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.
It is especially valuable to:
– Recovery technicians
– Quality Assurance/control and Regulatory Affairs professionals
– Production and quality assurance supervisors
– Quality, production and facilities engineers
– Managers and senior managers from Recovery Agents, Tissue Banks, Tissue Processors, and Tissue Distributors”
Michael Barile
Managing Partner of Barile & Associates Inc.