Courses Currently Being Developed
INTRODUCTION TO THERAPEUTICS MANUFACTURING
This course provides an overview of fundamental elements associated with the manufacturing of pharmaceuticals and medical devices. Students receive instruction on a variety of topics, including industry regulations and regulating agencies, drug and medical device development and manufacturing processes, supply chains and qualification techniques. Includes an exploration of potential career paths in therapeutics manufacturing as well as the roles and relationships between the various sectors of these industries. Hands-on laboratory activities are incorporated.
FACILITY OPERATIONS AND SAFETY
This course provides an understanding of the typical operations conducted in the different kinds of therapeutics manufacturing facilities that develop drug products and medical devices. The associated safety hazards are also discussed. Students learn about various components of manufacturing facilities, principles of sterile operations, potential hazards, safe work and environmental protection practices as well as protocol for maintenance and calibration within manufacturing facilities.
QUALITY SYSTEMS FOR THERAPEUTICS MANUFACTURING
This course offers a general overview of the quality assurance and quality control principles required by the therapeutics manufacturing industry. Through case studies and laboratory activities, students learn about the elements and importance of current Good Manufacturing Practices (cGMPs). Aspects of quality assurance systems, including documentation systems, standard operating procedures, risk management, validations, and inspections are addressed. Students are also introduced to quality control by performing various analytical tests.
This course provides a general overview of drug substance manufacturing processes used in therapeutics manufacturing. Students learn the difference between small and large molecule drugs, including an in-depth discussion of cell banking, upstream and downstream manufacturing processes, ion exchange chromatography, protein removal, scale-up, commercialization, and process development. Hands-on laboratory activities are incorporated.
This course provides an overview of drug product manufacturing processes used in the therapeutics manufacturing industry. Students learn about manufacturing of small and large molecule drugs, including common dosage forms, lyophilization, encapsulation, packaging and labeling, and product release. Also discussed are supply chains, product recalls, and additional production considerations. Hands-on laboratory activities are incorporated.