This program provides students theoretical and practice knowledge of Quality Assurance and Regulatory affairs and apply the knowledge and skills to the product development and manufacture and the maintenance of regulatory compliance.
Quality Assurance is critical to the success of product development and manufacture and the maintenance of regulatory compliance. This course is designed to provide participants with extended knowledge of Quality Management, Quality Assurance and Quality Control and to highlight the challenges associated with QA in the pharmaceutical field. In this course, it clarifies the roles and expectations of Quality Assurance throughout the entire process, from development through audits and inspections. Students will gain a wide range of knowledge of quality assurance guidance: GMPs, GLPs, ICH, GDPs, how to write SOPs, do an investigation, product complaints, product recall, returned goods, change control and CAPA.
Degree in science, health science, pharmacy or similar fields. Or a diploma with experience in clinical research or regulatory affairs
The Pharmaceutical Regulatory Affairs and Quality Assurance Program focuses on knowledge of regulatory strategic considerations and principals and practices of pharmaceutical quality assurance. After the completion of the program students will be eligible to apply in the following industries:
- Pharmaceutical companies
- Food products industry
- Chemical products industry
- Federal and provincial governments
- Clinical Research Organizations
- Environmental Laboratories
- Cosmetic industry
- Natural health product companies
Program Consultation: For further information, email firstname.lastname@example.org or call the Program Coordinator at 416-821-4876 or 647-996-5876
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