Workshop Overview

This interactive workshop will provide attendees with a practical framework for developing, validating, transferring, and maintaining flow cytometry assays intended for cGMP, clinical, and other regulated applications.

The workshop will connect scientific best practices with operational and regulatory expectations, with particular emphasis on developing fit-for-purpose validation strategies, establishing scientifically justified acceptance criteria, documenting assay performance, preparing methods for technology transfer, and identifying risks that could compromise reproducibility or delay implementation.

Topics will include:

• Defining an assay’s intended use and developing a fit-for-purpose validation strategy
• Developing an Analytical Target Profile (ATP) to document the assay’s intended purpose, required performance characteristics, reportable results, and applicable acceptance criteria
• Constructing an Ishikawa to systematically identify potential sources of assay variability and failure related to personnel, instrumentation, reagents, methods, samples, software, environment, and data analysis
• Using the ATP and Ishikawa diagram together to support risk assessment, validation planning, technology transfer, and assay lifecycle management
• Selecting and evaluating validation parameters such as specificity, accuracy, precision, linearity, range, sensitivity, LOD/LOQ, robustness, stability, and carryover
• Establishing appropriate controls, system-suitability criteria, and acceptance criteria
• Qualifying panels, antibodies, instruments, software, gating strategies, and data-analysis workflows
• Managing technology transfer between instruments, laboratories, operators, and testing sites
• Addressing differences among research-use-only, clinical, CLIA, cGMP, and IVD environments
• Supporting data integrity, documentation, audit readiness, change control, deviations, and assay lifecycle management
• Applying risk-based approaches to identify and mitigate common sources of assay failure
• Reviewing practical examples involving identity, purity, viability, potency, immunophenotyping, and cell and gene therapy assays

Several of the scientific and technical subjects covered during the workshop are also included in the SCYM(ASCP) examination content areas. Therefore, the workshop may be particularly valuable for attendees who are currently preparing for, or considering obtaining, the SCYM flow cytometry certification. The workshop is not intended to replace a comprehensive SCYM examination-preparation program, but it will reinforce several relevant principles and applications.

The program will incorporate real-world examples, interactive exercises, knowledge checks, and opportunities for attendees to discuss challenges encountered in their own laboratories.

Complimentary Educational and Technical Resources

All workshop attendees will receive:

• 30 days of complimentary access to all SuperNova Flow Cytometry educational products and resources, including its accredited flow cytometry courses and SCYM-aligned educational content
• 30 days of full access to FluoroFinder’s products, allowing participants to explore tools that support fluorochrome selection, panel design, instrument configuration, and other flow cytometry planning activities

These resources will allow participants to continue applying and expanding upon the concepts introduced during the workshop.

Learning Objectives

By the end of the workshop, participants will be able to:

• Describe the key elements of a fit-for-purpose flow cytometry assay-development and validation strategy for cGMP, clinical, and other regulated applications.
• Recognize the purpose and core components of an Analytical Target Profile (ATP) and how it can be used to connect an assay’s intended use with its expected performance characteristics.
• Use an Ishikawa diagram as a practical starting point for identifying potential sources of assay variability and failure, including risks related to samples, reagents, instruments, personnel, methods, software, and data analysis.
• Identify validation parameters and controls that may be relevant to a flow cytometry assay, such as specificity, precision, accuracy, robustness, stability, carryover, and system suitability.
• Recognize common scientific, operational, and documentation risks associated with assay development and technology transfer across instruments, laboratories, operators, and testing sites.
• Apply a practical risk-based framework to a representative flow cytometry assay case study and identify areas that may require additional characterization, mitigation, or validation.
• Identify opportunities to strengthen their organization’s flow cytometry training, documentation, and assay-development practices using the tools, templates, and continued educational resources introduced during the workshop.

Participants will leave with a clearer framework for evaluating their own assays, identifying potential gaps, and determining the next steps needed to support assay development, validation, technology transfer, and regulatory readiness.

CMLE Credits

Participants who successfully complete the workshop will be eligible to earn 2.0 Continuing Medical Laboratory Education credit hours.

To receive the credits, participants must attend the complete workshop, participate in the required educational activities, and successfully complete the post-workshop knowledge assessment. Eligible participants will receive a certificate documenting the workshop title, completion date, and CMLE credit hours earned.

SuperNova Flow Cytometry’s CMLE activities are approved through the American Society of Cytopathology, and the credits are accepted toward the ASCP Board of Certification Credential Maintenance Program. Participants should claim only the credit commensurate with their participation in the educational activity.