COURSE ID 3101

An Introduction to Current Good Tissue Practice (GTP)

Addressing Human Cell, Tissue, and Cellular and Tissue-based Products (HCT/Ps)

AVAILABLE Live
Date(s) and Time:
May 7, 2024
11:00am EDT - 12:30pm EDT
Duration: 90 Minutes

Can't attend the live course?
Select the on-demand option during registration, and we will automatically send you the recording when it is ready.

Course Instructor

Beatrice Huey

Early-Bird Offer

Limited Availability until April 4, 2024

$ 265
Price
$ 295
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

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:

  • Determine if your establishment is regulated solely under section 361 of the Public Health Services and the regulations in 21 CFR Part 1271 or if your HCT/Ps are regulated as drugs, devices, and/or biological products under section 351 of the PHS Act and/or the federal Food, Drug, and Cosmetic Act.
    • Determine if you are required to register and list your product.
    • Identify the requirements you must follow if you perform only some manufacturing operations.
    • List the “core” GTP requirements that place specific emphasis on procedures and practices to recover, process, store, label, package, and distribute HCT/Ps.
    • Explain the additional requirements of reporting and labeling.
    • Explain the exceptions to Subpart A.
    • Summarize what a quality program consists of.
    • Outline and execute a realistic plan for achieving and maintaining compliance with these requirements.
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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

Course Instructor

Beatrice Huey

Good Tissue Practice Specialist, University of Arkansas

Beatrice Huey’s Courses

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Team Training

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.

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