CITI Program Expands Training Portfolio with Regulation of Cell Therapy Products Course

Comprehensive training explores FDA oversight and current Good Tissue Practices (cGTPs) for professionals in the cell, gene therapy, and biologics industries.

FORT LAUDERDALE, FL, UNITED STATES, November 5, 2025 /EINPresswire.com/ -- CITI Program has announced the release of its newest online course, Regulation of Cell Therapy Products. Developed to meet the growing need for regulatory clarity in advanced therapies, the course provides essential guidance on the U.S. Food and Drug Administration’s (FDA) framework under 21 CFR 1271, which governs human cells, tissues, and cellular and tissue-based products (HCT/Ps). Learners will gain a comprehensive understanding of current Good Tissue Practices (cGTPs) and how they apply to donor eligibility, quality programs, and deviation and adverse event reporting.

"This course bridges the gap between scientific innovation and regulatory compliance by equipping professionals with practical knowledge they can immediately apply in their organizations," said Kathy Loper, Director of Regulatory Affairs at NMDP and course content leader. "Our goal is to make the complex FDA regulations more accessible to those shaping the future of cell and gene therapy," noted contributing author Paige McKibbon, also from NMPD.

Comprehensive Curriculum

The course integrates video presentations, expert commentary, and interactive learning components to enhance comprehension and engagement. The course features nine focused modules that provide a comprehensive overview of FDA oversight and compliance expectations for HCT/Ps. Topics include the history and scope of FDA regulation, application of cGTPs, donor eligibility, and key quality program elements such as personnel training, process validation, and complaint management. Learners also explore facility and environmental control standards, labeling and tracking requirements, and procedures for adverse reaction and deviation reporting. The course concludes with a 351 HCT/Ps review, highlighting the intersection of current Good Manufacturing Practices (cGMPs) and cGTPs. To deepen learning, the course enlists case studies that illustrate its key analyses and recommendations, helping learners apply regulatory principles to real-world scenarios. These modules offer foundational knowledge and practical insights into maintaining regulatory compliance in cell and tissue-based product development.

Who Should Take This Course

The Regulation of Cell Therapy Products course is for professionals seeking to better understand FDA regulations governing cell- and tissue-based products. It is particularly relevant for individuals in academic medical centers, blood and tissue banks, research institutions, and industry organizations, including faculty, principal investigators (PIs), sponsors, and students involved in the cell, gene therapy, and biologics sectors.

The course also complements CITI Program’s broader library of research ethics and compliance training, deepening understanding of the technical, regulatory, and ethical frameworks that underpin translational research and advanced therapy development.

Availability

Regulation of Cell Therapy Products is now available to organizations and individual learners through CITI Program's learning platform. Learn more by visiting the course page.

About CITI Program

For over 25 years, CITI Program has been a trusted global provider of research, ethics, compliance, and safety education. Its online courses serve millions of learners worldwide in areas including human subjects research, animal care and use, clinical trials, information privacy, and responsible conduct of research.

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