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Course ID:
2086

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Current Good Tissue Practices (cGTPs)

This course is not currently scheduled. Click on the Notify Me button to the left to be notified when it is scheduled.

This course is available as a client site course. Please click here for more information.

Who Should Attend
The US FDA current Good Tissue Practices Regulation constitutes a major change for Human Tissue Industry. This course is intended to provide hands-on training in the cGTPs for:

  • Recovery technicians
  • Production and quality assurance supervisors
  • Engineers
  • Managers
  • Senior managers from Recovery Agents, Tissue Banks, Tissue Processors, and Tissue Distributors

Description
The new current Good Tissue Practices Regulation represents a watershed change for the Human Tissue Industry. This course is intended to provide hands-on training in the working details and 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.

The third day includes a workshop on learning from the mistakes of others.

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