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COURSE ID 3101

An Introduction to Current Good Tissue Practice (GTP)

AVAILABLE On-demand
90 Minutes

On-Demand

Offering Price
$ 295
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Remember – 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.

ACCREDITATION CEU's - 0.2 IACET RAPS
View Course Outline

This course is intended for anyone who works for registered human cell, tissue, and cellular and tissue-based product (HCT/Ps) establishments which must comply with CGTP regulations.

It is especially valuable to:
– Executive Directors and CEOs
– Recovery Personnel
– Compliance Professionals
– MDs and Medical Directors
– Quality Assurance 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.

who should
attend?

LEVEL
Introductory
INTERESTS
Biotechnology / Biopharmaceutical Medical Devices / Diagnostics Pharmaceutical Science & Technology

The US FDA current Good Tissue Practice Regulations 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.

In this 90-minute intensive and accredited training, we will review the Public Health Service (PHS) and Federal Food, Drug, and Cosmetic (FD&C) acts and their regulatory authority. Discussion of the regulations and available guidance’s will be covered including Section 351 and 361 products and determination of minimally manipulation. We will dive deep into CGTPs, as outlined in Subpart D, including facilities, environmental controls, equipment, supplies and reagents, recovery, processing and process controls, labeling, storage, receipt, predistribution 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.

course instructor

Beatrice Huey
Good Tissue Practice Specialist, University of Arkansas

Beatrice Huey’s Courses
Ms. Beatrice Huey is currently employed as a Good Tissue Practice Specialist at the University of Arkansas for Medical Sciences in Little Rock, Arkansas. She has more than 20 years’ experience working in FDA-regulated environments and the tissue industry. She has extensive knowledge of current good tissue practice (CGTP), good manufacturing practices (CGMP) and good laboratory practice (GLP). She is skilled in quality assurance and control activities, policy development, regulatory compliance and strategic planning. Ms. Huey has been instrumental in ensuring compliance in more than 20 FDA inspections at the University.

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