Ontario College Graduate Certificate
45 weeks

Regulatory Affairs and Quality Operations


Companies that intend to develop and commercially distribute regulated pharmaceuticals and life-science products are required to have knowledge of the full spectrum of regulatory requirements in those industries. This program will provide students with the in-depth knowledge and hands-on training required to assist with navigating regulatory approval processes, primarily for pharmaceuticals, biotechnology, and medical devices with a secondary focus on food and herbal products. Students will specifically learn the process for developing successful regulatory applications that allow companies to proceed with the development and launch of new products. There are three semesters.

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Program Highlights

Students will develop the strong communication, negotiation, and project management skills necessary for the preparation of successful regulatory affairs applications and documentation. They will also practice their attention to detail and strategic thinking skills, all of which are critical for career progression within the highly competitive pharmaceutical and biotechnology industries. Students’ real-world experience is enhanced through a co-op work experience that is included in the program.


Level 1

Take all of the following Mandatory Courses:

This course examines the geographical, political, social, historical and cultural contexts for key current issues facing Canadians today. Students will learn about, reflect upon, and analyze Canadian issues, their roots, their meaning today, and their influence on our future. This course introduces international students to the conflicts, contexts, and challenges of Canada and what it means to be Canadian.

This course examines the concepts of citizenship, public space, political membership, civic responsibility, and belonging. Students will learn about the Charter of Rights and Freedoms, specifically fundamental freedoms, democratic rights, legal rights, and equality rights. The course also probes different aspects of the immigrant experience in Canada from the 1920s to the present. Topics include urban and rural settlement, immigration laws and public policy, labour, institutional development, gender and the family, religion, and social stratification.

This course will introduce graduate-level international students to communication within the Canadian workplace. Topics to be covered will include verbal, non-verbal and written communications, with a focus on cultural differences. Working individually and in groups, students will have ample opportunity for skill development.

This course will teach graduate-level international students the fundamentals of the job search, including resumes, cover letters, portfolios and interviews. The course will also examine workplace culture and on-the-job expectations in Canada. Students will become familiar with their rights as workers and Canadian employment standards as well as equity, diversity and inclusion in the workplace.

This course will prepare graduate-level international students for the learning environment in Canadian post-secondary institutions. Topics to be covered will include academic integrity, research methods and online learning. Students will be also be exposed to common teaching and learning methods used in graduate certificate programs, including case-based learning, problem-based learning and experiential learning. Students will work individually and in groups, and will have ample opportunity for skill development.

This course will introduce students to the structure and function of the main institutions of Canadian government. Student will learn about the history and evolution of Canada’s parliamentary system, the constitution, the role of the monarchy and Governor General, as well as the roles of the governing and opposing parties. Students will also learn about the legislative authority of provincial and municipal governments.

This course will introduce graduate-level international students to the Canadian health care system. Topics to be covered include, the history of health care, provincial and federal roles and responsibilities, health care occupations, and private health care, as well as current issues and trends. Students will learn how to access health care for themselves and their families.

Level 2

Take all of the following Mandatory Courses:

This course will introduce students to topics in regulatory document preparation such as standard operating procedures (SOP), records of training, batch documents, change control, stability documents, deviation, and investigation reports. Students will practice focused writing techniques appropriate to regulatory affairs.

This course will introduce students to the fields where the regulatory process is implemented and the corresponding role of the regulatory affairs professional. Students will conduct an industry and socio-economic impact analysis specific to the introduction of a new product and/or policy. Relevant provincial, federal, and international regulatory bodies will be reviewed as well as the international standardization in different industries (ISO institutes).

Course topics include preparation of quality control documentation at different stages of production and quality monitoring, the process of quality assessment in pharmaceuticals and biotechnology industries, and Good Laboratory Practice(GLP), Good Clinical Practice(GCP), and Good Manufacturing Practice(GMP) specific to pharmaceutical operations.

Course topics will include application and documentation processes involved in drug manufacturing, preparation and release of products by international standard requirement(ISO), specialized documentation for marketing of pharmaceuticals and biologics, and the socio-economic impact of introducing a new drug or biological therapeutic products (i.e. vaccines).

This course provides an overview of different chemicals and biological materials used in pharmaceutical and biotechnology industries. Students will also learn about safety precautions and regulatory documentations of these materials, as well as Canadian regulatory processes about hazardous chemicals.

This course introduces the essentials of the project management discipline, and prepares students to manage project teams, project schedules, budgets and quality requirements. Students learn the process of analyzing, creating and managing a functional project plan and the various project management processes for managing and controlling a project through to fruition. This course brings all of the Project Management Institute (PMI) knowledge areas of project management together into a consolidated whole, and gives the student an understanding of project management methodologies as well as the tools and techniques used to plan, execute and control various types of projects.

The purpose of a capstone project is to provide students with the opportunity to apply the knowledge and skills learned across all courses in the program to a large-scale project that’s reflective of a real-life work situation. This course is the first phase of the capstone project, where students will receive an overview of the project parameters and begin planning for both their individual and group contributions.

Level 3 

Take the following Mandatory Course:

This course introduces chemical and biological safety acts and regulations as outlined by PHAC, WHMIS, and PHO. It will explore regulatory approaches in different biotech industries (e.g. bio-containment area, sterile facilities). The course teaches and reinforces the need for ongoing professional development associated with occupational health and safety in a Canadian context.

Course topics will include importance of documenting the entire regulatory process, overview of the safety permit application and renewal process, practical guidelines for preparation and submission of TPP (Therapeutic Product Profile), internal audits, and relevant government agencies (PHAC).

This course will introduce bioethical considerations for life science industries. Students will explore the application of bioethics in different practice scenarios (e.g., sample collection, medical preference, clinical trial of therapeutics).

Course topics will include preclinical and clinical research practices in biotechnology companies, regulations specific to clinical diagnostic centers, medical device regulatory implications and the documentation associated with clinical research, and new device approval.

Regulations surrounding cannabis production and processing will be explored. Fundamental aspects of internal and external laboratory auditing will be taught. Students will prepare an audit plan for meeting laboratory accreditation requirements. Bioethics will be introduced relative to the moral issues of cannabis regulatory compliance. Specifics of Cannabis testing requirements while following the Cannabis regulations are taught. Safe Foods for Canadians Regulations as it pertains to edible cannabis products are examined.

This course will introduce food regulations regarding food safety and good manufacturing practices (GMP), including HACCP and other globally recognized food safety systems. The student will build the skills required to enable them to prepare customized preventative control plans (PCP).

This project-based course will engage students in completing a regulatory applicaton for a Canadian biopharmaceutical or biotechnology product. Students will plan the project steps and prepare the required documentation for each step. They will practice their presentation and negotiation skills periodically based on the faculty instruction.

This workshop will provide an overview of the Co-operative Education consultants and students’ roles and responsibilities as well as the Co-operative Education Policy. It will provide students with employment preparatory skills specifically related to co-operative education work assignments and will prepare students for their work term.


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