The Implementation of Cell Counting Standards (ISO 20391-1:2018 and ISO 20391-2:2019) Training Course

The Implementation of the ISO Cell Counting Standards training course is a partnership between ISCT and Standard Coordinating Body (SCB). This course was developed by the 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. 

Through this course, you will gain a fundamental understanding of cell counting terminology, methods, reporting, and processes for cell counts, sample selection, and data analysis. You will learn from experts how to apply the principles of quality indicators for evaluating the quality of a cell counting measurement process. 

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.

Contact raymond@isctglobal.org for more information.

COURSE CONTENT

LEARNING Objectives:

• 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 these standards.
• The impact of the ISO Cell Counting Standards Part 1 & 2 on meeting regulatory requirements.
• Determination of best fit methods and equipment for your cell counting needs.
• Understand the goals and importance of an experimental design for the cell counting measurement process.
• Understand and apply statistical analysis in cell counting.
• Learn how to use publicly available NIST applications for data analysis
• Know how to properly report your cell counting process for use in regulatory review.

Price (USD)

² Receive a 10% off when registering for 5 or more people from the same company/institution.
³ Industry Start-Up/Small Company is defined as companies less than 5 years old and has less than 15 employees.

Contact raymond@isctglobal.org for group registration rate.

Cancellation Policy: Registration cancellation must be made by email to isct@isctglobal.org at least twenty (20) business days before the course start date. A 10% administrative fee is applied to all cancellations.  Registration fee is non-refundable if it is cancelled within twenty (20) business days of the course start date.

“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. ”

“ISCT has long identified and taken measures to alleviate the skills shortages across the cell and gene therapy sector. ISCT has run a range of courses across the CGT sector, including forming our ISCT Early-Stage Professionals (ESP) Committee, responsible for our extensive Mentoring Program. Despite these efforts, growth in the CGT sector continues to outpace the professionals entering. This is a major issue for the sector that could become critical in the near future."