Clinical Research

Pharmacovigilance and Drug Safey

Regulatory Affairs

Quality Assurance

Quality Control

This course addresses the roles and responsibilities associated with Quality Assurance and Quality Control as they relate to the Canadian and North American Pharmaceutical, Food, Cannabis, Cosmetics, and Medical Devices industries. The critical components that make up a pharmaceutical quality system (e.g. GMP, GLP, validation, investigations, audits, corrective actions and risk assessment, etc.) will be discussed. This course also attempts to evaluate and apply QA/QC principles in order to achieve a quality pharmaceutical operation.

This course examines the relationship between micro-organisms, their human hosts and pharmaceutical products, cosmetics, medical devices, and Cannabis (medical marijuana and hemp). In lectures, students further learn about microbiological techniques to determine microbial populations and isolate specific spoilage micro-organisms. This is achieved by using conventional accredited laboratory methods including USP sterility, preservative challenge, and microbial limits testing methodology. Other topics include chemotherapeutic agents, their mode of action, resistance and susceptibility. Emerging pathogens and superbugs resistance to antimicrobial controls and their impacts.