COURSE ID 2086

Current Good Tissue Practices (cGTP): Establishing and Maintaining FDA Compliance

AVAILABLE On-demand
12 Hours

On-Demand

Offering Price
$ 2052
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“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”

course instructor

Michael Barile
Managing Partner of Barile & Associates Inc.

Michael Barile’s Courses
Mr. Barile has over thirty-five years of experience in the medical device, pharmaceutical, human tissue and biotechnology industries. He has held the executive quality assurance position in both start-up and large multi-national corporations, specializing in difficult turnaround situations. His depth of experience in both line and corporate management has given Mr. Barile a unique and practical hands-on expertise with a wide variety of challenges over a diverse range of product technologies.

Mr. Barile is Managing Partner of Barile & Associates Inc., a consulting firm comprised of a group of over forty senior quality, regulatory, operations and manufacturing professionals. Barile and Associates provides a range of services including software, process and equipment validation as well as quality system consulting, training, staffing, organizational development, auditing and 483/Warning Letter resolution and are experts in US FDA and international regulatory requirements. They have offices in North America, the Middle East, Asia and Europe.