Preparing For The Clinic: Qualifying Analytical Methods

If you are preparing a cell or gene therapy program for first-in-human studies, understanding how to qualify your analytical methods is a prerequisite for regulatory readiness. This webinar walks you through the scientific and regulatory basis for method qualification, distinguishing it from full validation and explaining when each is appropriate. You will also follow a hands-on example that applies qualification parameters to a realistic development scenario, giving you a concrete framework to assess your own methods.

Whether you are building your quality system from scratch or pressure-testing an existing approach, this session will help you identify gaps and make more informed decisions as you prepare your IND submission.