ETI 2170 - Quality Assurance & Regulatory Affairs

Institution:

Santa Fe College

Subject:

Description:

O 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 nanobiotechnology 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 d Full Description

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.sfcollege.edu

Phone Number:

(352) 395-5000

Regional Accreditation:

Southern Association of Colleges and Schools

Calendar System:

Semester

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