Effective personnel training and qualification can produce a competent workforce, which can lead to a reduction of errors/deviations, customer complaints, regulatory risk, and operational costs. This competency based education course addresses the measures required to stay in compliance with FDA regulations, and the requirements needed to implement an effective training and qualification program. This eLearning course also discusses specific responsibilities of personnel, records that need to be maintained, and how to measure training and qualification. Topics in this course include: Responsibilities, System Requirements, Training Specifics, Qualification Specifics, and Metrics. After completing this course, learners will be able to identify FDA’s requirements for personnel training and qualification, responsibilities of personnel, and how to measure training and qualification.