Regulatory Affairs

Overview

This online Regulatory Affairs graduate certificate program from Humber College focuses on developing the concepts, skills and techniques required to work in regulatory affairs in the pharmaceutical, health products, medical devices, biotechnology industries, food industries and other sectors that require a regulatory component. You will gain knowledge of the regulatory system, legislation, procedures and practices which relate to the development, manufacture, quality assurance and marketing of health-related and consumable products. 

The importance of internationally harmonized regulations and future trends in the industry is examined by analyzing relevant international and Canadian legislation and regulations. You will study a wide range of regulations and standards including good manufacturing practices (GMP), good laboratory practices (GLP), good clinical practices (GCP), good documentation practices (GDP), the International Organization for Standardization (ISO), the Canadian Food and Drugs Act (CFDA), the Environmental Protection Act, principles of regulatory compliance and inspections, drug establishment licensing, and related standards and guidelines.

Teamwork and communication skills are reinforced throughout the program, and you will acquire information technology skills that assist communication and data management specific to regulatory affairs.

Your Career

Our graduates typically pursue careers in the regulatory affairs departments in pharmaceutical, medical devices, biotechnology, consulting, inspection and quality assurance agencies, research institutes, government agencies, and any related industry or sector that requires regulatory expertise.