Courses
Regulatory Affairs and Quality Operations-2024/2025
| Level 1 | ||||
| Take all of the following Mandatory Courses: | ||||
| HLTH-1301 | Comm & Documentation in Reg Affairs 1 | 4 | ||
| 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. | ||||
| HLTH-1302 | Introduction to Regulatory Affairs | 4 | ||
| This course introduces healthcare product regulation Canada as positioned in a global market. It provides an overview of the lifecycles and regulatory processes of pharmaceuticals, medical devices, and natural health products, highlighting the principles and applicable legislation, regulations and guidelines that drive these processes. | ||||
| LAWS-6043 | Principles of Cannabis Regulations | 3 | ||
| 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. | ||||
| PHRM-1071 | Regulatory Affairs in Pharmaceuticals | 4 | ||
| 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). | ||||
| PHRM-1073 | Regulated Chemicals & Biologics | 2 | ||
| 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. | ||||
| MGMT-6084 | Project Management | 4 | ||
| 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. | ||||
| PHRM-1069 | Introduction to Capstone Project | 1 | ||
| 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. | ||||
| COOP-1020 | Co-operative Education Employment Prep | 1 | ||
| 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. | ||||
| Level 2 | ||||
| Take all of the following Mandatory Courses: | ||||
| HLTH-3068 | Health & Biosafety Regulations | 4 | ||
| 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. | ||||
| HLTH-3067 | Comm & Documentation in Reg Affairs 2 | 2 | ||
| 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). | ||||
| HLTH-3066 | Bioethics in Life Science | 3 | ||
| 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). | ||||
| HLTH-3065 | Clinical Research Regulations | 3 | ||
| 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. | ||||
| PHRM-1072 | QA in Pharmaceuticals & Life Science | 4 | ||
| 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. | ||||
| SFTY-6012 | Food Safety, Traceability & QA | 4 | ||
| 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). | ||||
| PHRM-3031 | Capstone Project | 3 | ||
| 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. | ||||
| Program Residency | ||||
| Students Must Complete a Minimum of 12 credits in this program at Fanshawe College to meet the Program Residency requirement and graduate from this program | ||||