6.0 Contact hours. This course takes a proactive approach to building or modifying a regulatory Quality Management System (QMS) that aligns with CLIA, complies with FDA regulations, and accelerates Laboratory Developed Test (LDT) development. Learners will explore LDT history, FDA oversight, and the VALID Act of 2020 while identifying compliance strategies. Through crosswalk analysis, participants will compare QMS standards with regulations, address gaps, and create a framework that ensures compliance and efficient test development.            

For a full description and to learn more:https://skill-hub-academy.com/courses/developing-a-quality-management-system-for-manufacture-of-laboratory-developed-tests/