BIOT 2460 Advanced Topics in Biotechnology

3 (lecture only) Credit Hour(s)

This course covers information about regulatory agencies, good lab, clinical and manufacturing practices (GxP), institutional committees, quality control, management styles, lab hygiene, safety and identifying hazards related to working in a laboratory setting. This course is required for students in the traditional Biotechnology track, and is recommended for all students who will work in a laboratory.
Student Learning Outcomes:

Define or identify aspects of the history, structure, and functions of the FDA
Define and identify aspects of research misconduct and conflicts of interest in research.
Define or identify all aspects related to Good Lab Practices, Good Manufacturing Practices, Good Clinical Practices, and Good Documentation Practices (GxP).
Define or identify aspects of Quality Assurance and Quality Control.
Define or identify aspects of Institutional Compliance and Committees and Six Sigma management practices.

Prerequisite(s): BIOT 1010 with a grade of “C” or better or permission of the instructor