Prerequisites: Program placed, BIO 180 with a “C” or better or biotechnology program head permission
This course prepares students to work effectively in a scientific field and explains the basics of the regulatory and quality environments encountered in a biotechnology or pharmaceutical field. The course surveys the principles and practices used on a day-to-day basis in regulatory affairs and quality systems.
This course is designed to provide an introduction to the regulations and quality control procedures for the biotechnology industry. Students will be introduced to concepts and practices involved in maintaining quality control standards in the biopharmaceutical manufacturing industry. This course is designed to help students learn the importance of writing and following standard operating procedures (SOPs), complying with environmental health and safety standards, and complying with current good manufacturing practices (cGMPSs). The course will also cover effective communication and documentation skills, information management, validation support, and the importance of equipment maintenance and troubleshooting.