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

ABOUT THE COURSE

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 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. 

This course will give you a fundamental understanding of cell counting terminology, methods, reporting, 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. 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.

COURSE CONTENT
  • 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.
LEARNING OUTCOMES
  • 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.
  • Know the impact of the ISO Cell Counting Standards Part 1 & 2 on meeting regulatory requirements.
  • Determine the 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.


View Course Outline


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
Re-examination fee4 (valid within one month after failing the course assessment.) $250 $250 $250

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Self-paced, on-demand modules
12 hours of learning


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ACCESS THE COURSE

DESIGNED FOR:
  • Laboratory professionals in biomanufacturing, tissue engineering, and medical laboratories
  • Regulatory professionals involved in cell product development and evaluation 


ELIGIBILITY REQUIREMENTS: 

  • None
UPON COMPLETION, YOU WILL RECEIVE:
  • An electronic copy of ISO 20391-1:2018 and ISO 20391-2:2019 Standards
  • SCB certificate with an 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. 

CONTACT US

    If you need assistance with registration or have questions, please contact us. 

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    “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."

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