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Nov 21, 2024
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BMED 2300 - Introduction to Quality Assurance
Credits: 3
This course will provide students with an in-depth understanding of the role quality plays in an industrial environment regulated by the Food and Drug Administration (FDA). The course will cover the responsibilities of quality assurance during the engineering, manufacturing, and production of a product. Topics will include management responsibilities, design control, production and process controls, continuous improvement, and methods and tools used to support quality assurance. The ISO standards, the regulatory requirements mandated by the FDA, and the European Medical Devices Directive (MDD), are also covered.
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