ETI 2170 - Quality Assurance and Regulatory Affairs

Credit Hours: 3.0
Prerequisite(s): None
Corequisite(s): None
This is a manufacturing course intended for biotechnology majors focusing on the quality assurance aspects of working in a regulated environment. This course will cover the principles of quality assurance with applications to regulatory affairs used in biotechnology and Nano biotechnology manufacturing. Course work will include topics in quality, regulatory affairs, ethics, current good manufacturing practices, audits, inspections, regulatory submissions, post-approval surveillance, globalization, international trade, and appropriate documentation. Using case studies from industry, the laboratory will detail typical biotechnology quality assurance procedures with the appropriate manufacturing documentation, focusing on labeling and product documentation.
Occupational (A.S. and A.A.S.)