Self-Paced Online Course

3 hours of learning

Self-paced, on-demand instructional modules.

Course Access

90-day access

Structured, self-paced access following enrollment.

Essentials of Cell Therapy Product Manufacturing, Qualification, and Validation

This course provides a concise overview for professionals looking to learn the essentials of cell product development, qualification, validation, stability, and regulatory submissions.

Based on Past Participant Survey Results

92%

Found the learning platform easy to navigate

90%

Rated instructors as knowledgeable and well organized

88%

Found the course valuable to their work

Designed For

Laboratory professionals who have completed the Cell Product Handling & Regulatory 101 course or have more than 3 years of experience in a cell processing lab.

Price (USD)

Category	ISCT Members	Non-Members
Technologists / Pharmacist / Nurse Practitioner / Nurse	$100	$450
Students / Resident / Fellow / Postdoc	$85
Academia	$125
Industry	$200
Tier 1 & 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 or Non-Members from the same company or institution.

Contact: workforcedevelopment@isctglobal.org

Tier 1 & Tier 2 Reduced Rate

Tier 1 and Tier 2 countries are listed here.

Reduced rates available only for Academic / Government / Non-Profit / Technologist / Pharmacist / Nurse.

Contact 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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Developing a CAR-T Program
Developing a Validated Assay That Will Please the FDA
Role of Manufacturing in Regulatory Submissions
Cryopreservation and Stability

ELIGIBILITY REQUIREMENTS

None

Understand the workflow for developing a CAR-T program
Know the critical path and steps to translate process development into GMP production

Bruce Levine

PhD

Past President
ISCT

ISCT has long identified and taken measures to alleviate the skills shortages across the cell and gene therapy sector. Despite these efforts, growth in the CGT sector continues to outpace the professionals entering — a major issue that could become critical in the near future.

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

“The course was well presented and the content was strong. I was genuinely impressed with how clearly the material was delivered, and it made the overall learning experience feel smooth and worthwhile.”

Mark B.

“Great presenter, I had no issues following along. The sessions were easy to keep up with, and the explanations helped me stay engaged and confident in what I was learning throughout the course.”

Chen Y.

“The instructors were knowledgeable and effective overall. When sessions included more structured regulatory explanations and real examples, it made the content much easier to understand and apply.”

James R.

Planning Committee

Wade Atkins MS, MT (ASCP) SBB, CQA (ASQ)

Department of Transfusion Medicine, NIH

USA

Diane Kadidlo, BSc, MT (ASCP) SBB

University of Minnesota

USA

Emily Hopewell, PhD

Indiana University School of Medicine

USA

Principles & Applications of Cell Therapy Biomanufacturing, Characterization, Regulatory

Hybrid 9-Week Program Self-paced + Live Virtual

Learn More →

An online course blending self-paced modules with live discussions featuring CGT experts. Designed to deliver essential best practices in cell therapy biomanufacturing, characterization, and regulatory frameworks.

Format: 12 hours self-paced 4 hours live-virtual

Essentials of Cell Therapy Product Manufacturing, Qualification, and Validation

Essentials of Cell Therapy Product Manufacturing, Qualification, and Validation

Planning Committee

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Principles & Applications of Cell Therapy Biomanufacturing, Characterization, Regulatory

Questions?