Do you want to host FDA Staff? FDA announces Experiential Learning Site Visit Program

The U.S. Food and Drug Administration (FDA) is announcing the Fiscal Year 2025 CDER Office of Pharmaceutical Quality (OPQ) Experiential Learning Site Visit Program (ELSVP). ELSVP is an educational initiative aimed at enhancing FDA staff's understanding of pharmaceutical manufacturing processes, innovations, and industry challenges. The program provides FDA staff with the opportunity to engage directly with pharmaceutical industry sites, gaining hands-on experience and insights into contemporary manufacturing and quality practices.

Background

The OPQ is responsible for ensuring the quality of medicines produced for the U.S. market. To better align regulatory oversight with the current industry practices and innovations, the FDA established the ELSVP as a mechanism for improving staff knowledge of pharmaceutical processes. This initiative supports FDA's mission to apply a science- and risk-based approach to pharmaceutical regulation.

How it works

The ELSVP is a site-based learning initiative where FDA staff visit pharmaceutical manufacturing facilities. These visits provide FDA reviewers, inspectors, and scientists with the opportunity to observe real-world manufacturing technologies and quality control systems. Key areas of focus include continuous manufacturing, advanced analytical tools, and comprehensive quality management systems. The program relies on voluntary participation from pharmaceutical manufacturers who apply to host FDA staff at their facilities. Participants from the FDA are then matched with the appropriate facilities for immersive, practical learning experiences.