The Implementation of ISO Cell Counting Standards

Self-Paced Online Course

10 hours of learning
Self-paced, on-demand modules.

Course Access

90-day access
Structured learning following enrollment.

The Implementation of the ISO Cell Counting Standards course is a partnership between ISCT and the Standard Coordinating Body (SCB). This course was developed with input from Subject Matter Experts (SMEs), including NIST, FDA, and device manufacturers, who created the ISO 20391-1:2018 (Part 1) and ISO 20391-2:2019 (Part 2) Standards.

This course provides a foundational understanding of cell counting terminology, methods, reporting, processes, sample selection, and data analysis. Participants will learn how to apply quality indicators to evaluate the performance of cell counting measurement processes. As part of the course, you will receive an electronic copy of ISO 20391-1:2018 (Part 1) and ISO 20391-2:2019 (Part 2) Standards.

At the end of the course, you will be confident in implementing ISO Cell Counting Standards and using consensus standards in the regulatory process. This will improve the quality and comparability of your cell counting process and can shorten regulatory review.

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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

Designed For

Laboratory technologists, research scientists, and quality control personnel in cell biomanufacturing and tissue engineering involved in cell counting and related applications.

Learn how to implement ISO Cell Counting Standards Part 1 & 2
Demystify the standard development process and the role of consensus standards in the regulatory process
Understand the scope, requirements, and limitations of ISO Cell Counting Standards
The impact of ISO Cell Counting Standards Part 1 & 2 on meeting regulatory requirements

Price (USD)

Category	ISCT Member	Group Member¹	Non Member
Academia²/Non-profit	$1,295	$1,165.50	$1,835.50
Industry	$1,595	$1,435.50
Industry (Start-up / Small Company³)	$1,395	$1,255.50
Tier 1 and Tier 2 Reduced Rate¹	$906.50	—	—
Re-examination fee⁴ (valid within one month after failing the course assessment)	$250	$250	$250
10% Group Registration Discount available for 5+ Members / Non-Members from the same institution

Group Registration Discount:

Receive 10% off when registering 5+ ISCT Members / Non-Members from the same company or institution.
Contact workforcedevelopment@isctglobal.org to obtain the discounted Group Registration Rate.

¹ Tier 1 and Tier 2 Reduced Rate:
Tier 1 and Tier 2 countries are listed here. Reduced rates are available only for Academic, Government, Non-Profit, Technologist, Pharmacist, and Nurse registrants. For eligibility, contact workforcedevelopment@isctglobal.org.

² Please contact ISCT Head Office at workforcedevelopment@isctglobal.org to receive a discount code for Academia Members.

³ Industry Start-Up / Small Company is defined as companies less than five years old and with fewer than 15 employees.

⁴ For re-examination, please contact workforcedevelopment@isctglobal.org.

Learn how to implement ISO Cell Counting Standards Part 1 & 2.
Demystify the standard development process and understand the role of consensus standards in regulatory pathways.
Understand the scope, requirements, and limitations of ISO Cell Counting Standards.
Evaluate the impact of ISO Cell Counting Standards Part 1 & 2 on meeting regulatory requirements.
Determine best-fit methods and equipment for specific cell counting needs.
Understand the goals and importance of experimental design in cell counting measurement processes.
Apply statistical analysis techniques to cell counting data.
Use publicly available NIST applications for data analysis.
Properly document and report cell counting processes for regulatory review.

ELIGIBILITY REQUIREMENTS

None

SCB Partner

Standards Coordinating Body

ISO Cell Counting Standards
Partner

At the end of the course, you will be confident in the implementation of ISO Cell Counting Standards and the use of consensus standards in the regulatory process. This will improve the quality and comparability of your cell counting process and can shorten regulatory review.

Our partnership with ISCT brings the largest cell manufacturing research and education consortium together with the largest global cell & gene therapy society to deliver critically needed workforce training for CGT.

UPON COMPLETION, YOU WILL RECEIVE:

An electronic copy of ISO 20391-1:2018 and ISO 20391-2:2019 Standards
SCB certificate with ANSI accreditation
Access to expert guidance via the course discussion forum
An electronic version of the course booklet

Note: ANSI accreditation for this course is currently under review. SCB certificates with accreditation will be provided upon approval.

What Past Participants Are Saying

“Overall, the course was thoughtfully designed and easy to navigate. I really liked the video format and having the slides available, it made reviewing key ideas later much easier and helped me apply them in my own work.”

Elena R.

“Excellent course, well organized and packed with useful insights. The material was thorough and clearly laid out, which made it easier to see how all the pieces fit together in real clinical and manufacturing environments.”

David K.

“The content closely matched the learning goals, and the interactive elements stood out. The Q&A discussions and real-world examples kept the sessions engaging and helped the concepts stick.”

Maria C.

ISO The Implementation of Cell Counting Standards

The Implementation of ISO Cell Counting Standards

Questions?