14 courses with the subject QRA, each shown exactly as we captured it from the college's catalog, with every element we hold. Where the wording looks broken, that is our reading of the catalog, not the college's text.
QRA 500Food, Drug and Cosmetic Act3
This course is primarily an introduction to the Food Drug and Cosmetic Act and the regulation of foods, drugs, biologics and devices by the U.S. Food and Drug Administration (FDA). Students will learn the basic statutory and regulatory authorities under which the FDA operates. Because the practice of food, cosmetics biologics and drug law occurs in a rapidly changing technological, legal, and policy environment, this course aims to give the student the ability to keep on top of current trends that they will use and encounter in their profession. Credits: (3,0)
The course covers topics in quality assurance principles, audit techniques, audit types, audit presentation and reports. Audit procedures for GMP and GLP for drugs, biologics, devices, food and cosmetics will be addressed with focus on key areas of inspection readiness and quality systems audits. Students will work with Case studies to simulate a real-world audit using he tools and methodologies learned. Prerequisite(s): QRA 500, 501, and 502 Credit(s): 3 Credits: Credits:3 (3,0)
This course provides a detailed analysis of the regulatory processes for new product approvals in drugs, biologics and medical devices outside of the United States. Students gain experience in comparing the European, Chinese and other regulatory registration trends with those of the United States. Students will explore Stringent Regulatory Authorities (SRA), Brazilian regulatory agency (ANVISA) and the World Health Organization (WHO) program by he analysis of topics such as clinical trials, regulatory intelligence, Drug-device combinations and others. Prerequisite(s): QRA 500 and 501 Credit(s): 3 Credits: (3,0) Page 280 • Course Index • 2026-2 RESEARCH ALIGNED MENTORSHIP (RAM)
