ETI 3173C - Applied Manufacturing Quality Assurance and Quality Control

Credit Hours: 3.0
Prerequisite(s): MAC1105 with C and STA2023 with C
Corequisite(s): None
This is a manufacturing course intended for biotechnology majors focusing on the international regulatory affairs, compliance, and quality assurance aspects of working in a regulated environment. This course will examine the development of biotechnology products. This course will cover the principles of quality assurance with applications to international regulatory affairs used in biotechnology including the medical diagnostic, biopharmaceutical and medical device sectors. Course work will include topics in basic principles of industry, quality, regulatory affairs, major departmental functions, international regulatory agencies, harmonization, current good manufacturing, laboratory and clinical practices, audits, inspections, regulatory submissions, post-approval surveillance, globalization, international trade, and appropriate documentation.
Bachelor Course