ASCP/ACP-Accredited & CMLE-Granting Flow Cytometry Training: Developing & Validating GMP & IVD-Ready Flow Cytometry Assays for Regulatory Success
Time: 1:05 pm
day: Workshop
Details:
Flow cytometry is a vital tool for developing robust, GMP and IVD compliant assays, critical to cell therapy product characterization and regulatory submissions. This ASCP/ ACP-accredited and CMLE-granting session combines expert teaching with interactive tools to guide you through designing and validating flow cytometry assays for drug characterization and manufacturing, as well as for IND or BLA filings; all while earning recognized CMLE credits towards your specialist in cytometry certification (SCYM) and CLIA/CAP requirements.
Join this workshop to:
- Earn three recognized CMLE credits through interactive learning, quizzes, and a certificate signed by an ASCP/ACP-accredited instructor
- Master the design and validation of flow cytometry assays, that meet GMP and IVD standards and regulatory requirements for flow cytometry assays such as potency, product identity, safety testing, and clinical trial immunomonitoring
- Gain hands-on experience using commercially available tools (e.g. Cytek Panel Designer) with expert guidance on panel design
- Learn best practices for transitioning from research-use-only (RUO) to GMP to IVDcompliant workflows, and avoid common pitfalls in IND/BLA submission
