Regulatory Compliance Course Calendar, Northwestern University School of Professional Studies - Northwestern School of Professional Studies

Program Courses

Please note that course schedules may be amended due to low enrollment, faculty availability, and/or other factors.

Online Sync Sessions are an integral part of the online learning experience. Additional information about learning concepts and assignments may be discussed and sync sessions offer valuable opportunities for students to interact with their faculty and peers during the term. We encourage all students to attend live, but if they are unable to, sync sessions will be recorded and posted within Canvas to allow for an asynchronous model of success as well.

QARS 421-DL : Applied Quality and Regulatory Practices

Description

This course explores quality, standards, and compliance regulations in the laboratory, as well as a review of the laboratory system components that support compliance with quality system regulations and science-based laboratory management. Includes the following specific topics: managing a quality system within an analytical laboratory environment; laboratory certification and accreditation; calibration, qualification, and maintenance of laboratory equipment, review of facility requirements; study of laboratory deviations, failure investigations, and compliance with out-of-specification requirements (CAPA); test method development, system suitability, and method verification and validation; installation qualification, operational qualification, and performance qualification protocols; notebooks and maintenance logs; training staff and tracking training.Quality Systems track course.It is highly recommended that students complete biostatistics prior to taking this course.