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The application of statistical methodologies to the analysis and solution of quality and management problems, including hypothesis testing, probability theory, control charts, sampling, multiple regression, and the design of experiments. Focus is on statistical process control and the use of statistics in testing, inspection, and production. Students introduced to National Committee for Clinical Laboratory standards as well as Clinical and Laboratory Institute consensus standards. Topics covered may include validation concepts for plant, process, cleaning, sterilization, filtration, analytical methods, and computer systems; good automated manufacturing practice; Institute of Electrical and Electronic Engineers Software Quality Assurance Plan, new electronic requirements, and relationships to good manufacturing practice; national (FDA) and international (EU) regulatory affairs for quality systems requirements in development and manufacturing. Prerequisite: QARS 410 or consent of instructor.
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