Who Should Attend: This course is designed for anyone who works for any facility involved in the collection, processing, testing or shipping HCT/Ps. All functions in the facility: technical, administrative, regulatory, manufacturing, quality assurance, and all levels from the most senior to the most junior staff member will benefit from this course.
Click on the titles below to learn more about each session. When live sessions are available, sign up anytime and receive links to recordings of any individual sessions or all three sessions. Although designed to be taken in a series, you may pick and choose individual sessions, as they are designed to be stand-alone units. When you are ready, click on the “Register Now” button to sign up for individual sessions or the full course.
Each 60-minute session is just $339 per session or $1018 for all three sessions! Great group discounts are available.
FREE EXCERPT! Want a preview of Session 1 from the GTP Course?
Click HERE to watch an excerpt from Session 1 anytime.
Session 1: Introduction to the World of Drug Regulations and How 1271 and GTPs Fit into the Picture
Instructor: Dr. Laureen Little
Format: On-demand recording available now.
Content: Review of the PHS and FD&C acts and their regulatory paradigms. Descriptions of the regulations and available guidances. Section 351 and 361 products and determination of minimally manipulation. Discussion about the 4 difference paradigms for manufacturing therapeutic products (drugs, biologics, devices and tissue/transplantation). History and discussion about how and why the regulations were implemented. The impact of health issues identified for transplant recipients. Description of 21 CFR 1271 regulations.
Content: GTP and GMP regulations as they apply to 351 and 361 products will be reviewed in-depth. Case studies and FDA audit observations will be discussed.
Good Tissue (cGTP) Requirements – What They Are, How to Comply and Hot Topics
Instructor: Dr. Laureen Little
Format: On-demand recording available now.
Content: Part 1271, Subparts D thru F. Deep dive into cGTPs, as outlined in Subpart D, including facilities, environmental controls, equipment, supplies and reagents, recover, processing and process controls, labeling controls, storage, receipt. Predistribution shipment and distribution. Recent HCT/P Inspection results.
COPYRIGHT: U.S. Copyright Law protects the program you are about to attend from unauthorized duplication. Multiple participants are not authorized to share access provided to a single registrant. For each individual who attends, a single dedicated seat license must be purchased, or a group rate must have been previously arranged with FasTrain. FasTrain reserves the right, at its discretion, to cancel or interrupt access to a web-based training class without notice, or to invoice and collect the group rate payment for the class from the single registrant if this requirement has been violated.
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