Cell Product Handling & Regulatory 101

Self-Paced Online Course
Self-paced, on-demand instructional modules.
Course Access
Structured, self-paced access from enrollment.

Cell Product Handling & Regulatory 101

The Cell Product Handling & Regulatory 101 is a three-hour, on-demand course developed for professionals new to the cell and gene therapy field. This course covers the fundamental knowledge important for working in Cell and Gene Therapy (CGT) labs—including cell collection, sample processing, storage, distribution, quality control and regulatory requirements.

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Based on Past Participant Survey Results
98%
Said the course content was relevant
95%
Felt the course was well organized with adequate time per segment
94%
Found the training valuable to their work

  • Collections
  • Processing and QC
  • Quality Assurance / Regulatory
  • Product Storage, Distribution & Logistics
  • Apply best practices for sample collection, processing, and storage.
  • Understand the QA and regulatory requirements for CGT products.
Designed For

Laboratory professionals new to, or with up to three years of experience in, a cell processing lab.

Price (USD)
Category ISCT Member Non-Member
Technologists / Pharmacist / Nurse Practitioner / Nurse $100 $450
Students / Resident / Fellow / Postdoc $85
Academia $125
Industry $200
Tier 1 and Tier 2 Reduced Rate1 $87.50
15% Group Registration Discount available for 5+ Members / Non-Members from the same institution.
Group Registration Discount

Receive 15% off when registering 5+ ISCT Members / Non-Members from the same company or institution.

Contact ISCT: workforcedevelopment@isctglobal.org

1 Tier 1 and Tier 2 Reduced Rate:
Eligible countries listed here.
Reduced rates apply only to Academic / Government / Non-Profit / Technologist / Pharmacist / Nurse categories.

Contact ISCT at workforcedevelopment@isctglobal.org to obtain the reduced rate.

The Resource Hub provides supporting materials to help reinforce learning before, during, and after the course.

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ELIGIBILITY REQUIREMENTS
  • None
UPON COMPLETION, YOU WILL RECEIVE:
  • 3 CMLE Credits
  • Certificate of Course Completion from ISCT

Note: Completing all training modules and passing the quizzes is mandatory to receive the course completion certificate.

ACCREDITED BY:
3 CMLE Hours
What Past Participants Are Saying

“Overall, I found the course to be very well designed and easy to follow. I especially appreciated the video-based format and having access to the slides, which made it easier to review key concepts afterward and apply them to my own work.”

Ananya R.

“Great course, very well organized and highly informative. The content was comprehensive and clearly structured, which helped me understand how the different components connect in real clinical and manufacturing settings.”

Hana T.

“The material aligned closely with the learning objectives, and I really valued the interactive elements. The Q&A explanations and practical examples made the sessions engaging and helped reinforce the concepts in a meaningful way.”

Omar H.

Planning Committee

Alexey Bersenev
Wade Atkins MS, MT (ASCP) SBB, CQA (ASQ)
Department of Transfusion Medicine, NIH
USA
Alexey Bersenev
Diane Kadidlo, BSc, MT (ASCP) SBB
University of Minnesota
USA
Alexey Bersenev
Emily Hopewell, PhD
Indiana University School of Medicine
USA

Essentials of Cell Therapy Product Manufacturing, Qualification, and Validation

Self-paced

Introductory-level course covering GMP product development fundamentals, CAR-T program development, qualification, validation, stability, and GMP production workflows.

Target Audience: Lab professionals with 3+ years experience Graduates of Cell Product Handling & Regulatory 101 Early-career CGT professionals

Questions?

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