ETI 3173C - Applied Manufacturing Quality Assurance and Quality Control ETI 3173C - Applied Manufacturing Quality Assurance and Quality Control 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
Prerequisites: MAC1105, STA2023