Chemistry - Regulatory Affairs and Quality Control

Regulatory Affairs and Quality Control (BIOT 2320)

Total Credits: 4
Lecture Credits: 2.50
Lab Credits: 1.50

Description: This course will address the federal regulations and global, environmental and ethical considerations of bioscience products. You will learn to participate as a responsible stakeholder by following Food and Drug Administration and Environmental Protection Agency regulations. You will gain an understanding of current Good Manufacturing Practices, Quality Control (QC), Good Laboratory Practices, Good Clinical Practices and current Good Tissue Practices. You will apply notions of civic responsibility through study of international regulations, global perspectives, intellectual property laws, and import/export considerations. Laboratory sessions will provide hands-on experience in QC procedures, scientific measurements and safety regulations. You will learn to prepare reagents and solutions, adopt aseptic techniques, sterilization procedures, clean-room procedures and use of various instruments. You will practice critical documentation aspects and learn about Standard Operating Procedures.

Topical Outline:

Learning Outcomes:

Prerequisites: 

CHEM 1151.