BIO411 Regulatory Affairs & Biosafety for Biotechnology

[3–0, 3 cr.]

This course introduces the regulatory, quality, and biosafety frameworks governing biotechnology research, development, and commercialization. Students examine the biotechnology product lifecycle, regulatory approval pathways, Good Practice (GxP) quality systems, clinical trial requirements, and documentation standards. The course also covers biosafety principles, biological risk assessment, biosafety levels, containment practices, and the responsible management of genetically modified organisms and advanced biotechnology products. Emphasis is placed on regulatory compliance, ethical responsibility, and global standards in biotechnology innovation. As a required core course, it ensures that every graduate of the minor develops competency in governance, biosafety, and research ethics.

Pre- requisite: BIO410 Biotechnology