Course Schedule
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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.