From Science to Compliance: Building Trusted NGS-Based GMP Assays

In this webinar, Giuseppe Semplicio, GMP Project Manager at Genedata, explains how organizations can transform NGS methods into trusted GMP assays by combining scientific understanding, computational analysis, and validation. You will learn why assay qualification is essential for establishing scientific validity, how biological questions and intended use shape validation strategies, and what is required to build confidence in NGS-based decisions in regulated environments. Giuseppe also demonstrates how Genedata Selector Playbooks support the operationalization of validated NGS workflows through controlled execution, traceability, automation, and scalable validation approaches.

This talk is part of Genedata’s Open Forum series on NGS-based workflows for biopharmaceutical R&D and manufacturing.