Standardize Your Cell Counting with ISO – Virtual & Hands-On Training

Take the On-Demand Course Now and Attend the Hands-On Course for Free

The Standards Coordinating Body (SCB) is offering a unique two-part training opportunity to help professionals standardize and optimize cell counting processes using internationally recognized ISO standards. These standards are also recognized by the FDA’s Center for Biologics Evaluation and Research (CBER) as part of their Voluntary Consensus Standards (VCS) recognition program. This training is ideal for anyone working in cell and gene therapy manufacturing, quality control, regulatory affairs, research, assay development, or any other field where reliable cell counts are essential.

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The Implementation of ISO Cell Counting Standards

Flexible | Online | Self-Paced

Build your foundational understanding of cell counting variability and how to control it using ISO standards. Developed with input from experts at NIST, FDA, and major device manufacturers, this course dives deep into:

• Implementation of the ISO 20391-1:2018 and ISO 20391-2:2019 standards

• Best practices for consistent, reproducible cell counting

• Common sources of variability and how to mitigate them

• Application of the standards to support regulatory submissions

• Statistical analysis of cell counting data

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SCB Hands-On ISO Cell Counting Implementation Course

2-day | Montgomery College Germantown Campus| November 6–7, 2025

Apply what you’ve learned in the virtual course through practical, lab-based training led by NIST subject matter experts. This intensive two-day workshop offers: • Hands-on use of instruments and technologies aligned with ISO standards • Live demonstrations and guided experiments

• Troubleshooting scenarios to address real-world variability • Opportunities to engage directly with the experts who developed the standards • Practical tools for implementing ISO standards in your own lab or workflow ________________________________________

Bundle Offer

Until October 31, 2025, register for the The Implementation of ISO Cell Counting Standards now and receive FREE access to the hands-on course in November. Additional Offer

• Free for alumni who have taken the self-paced Implementation of ISO Cell Counting Standards

• Free registration is also available for federal employees

All others pay a small fee to cover lab consumables and course materials.

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• Bundle offer through ISCT.

• Standalone Hands-on course: Register for the Hands-On SCB ISO Cell Counting Implementation Course here.

• Contact us for more information

FDA Recognition of the ISO Cell Counting Standards

The two-part ISO Cell Counting Standard, part 1, ISO 20391-1:2018, General guidance on cell counting methods and part 2, ISO 20391-2:2019, Experimental design and statistical analysis to quantify counting method performance have been recognized by the FDA’s Center for Biologics Evaluation and Research (CBER), as part of their Voluntary Consensus Standards (VCS) recognition program. CBER encourages the use of appropriate standards in the development of CBER-regulated products. VCS, such as the ISO Cell Counting Standard, help stakeholders meet regulatory requirements more efficiently and increase regulatory predictability for Regenerative Medicine Therapy (RMT) products.