4019 - Good Manufacturing Practice in Biomanufacturing

Course Description

Advances in the development of vaccines and cell and gene therapies have brought to the forefront preventive medicine as well as new treatment options for life-impacting conditions, including infections, cancers, diabetes, and heart disease. Vaccine production is expanding in Canada and, as of April 2023, over 2,300 cell and gene therapy products were undergoing clinical trials which can take up to eight years to complete. As a result, health regulators are planning for a significant increase in these products in the next five years.  

As the industry grows, its advanced manufacturing capacity will also expand and evolve. There is a need for skilled operators to work in the specialized Good Manufacturing Practices (GMP) facilities that will be critical for bringing vaccines and therapies to patients, both in the clinical trial phases and once these products are approved. The speed at which life-saving vaccines and therapies are being produced demands a trained workforce who can operate the manufacturing facilities, including clean rooms, needed to bring treatments to patients.

Completing this micro-course, along with the others comprising the Upskilling in Biomanufacturing Program,  provides an opportunity to have your resume moved to the top of the pile by demonstrating to both Canadian and international employers that you already possess the skills required to work in a GMP-compliant facility.

This two-part micro course teaches best practices for working in a GMP environment. The first part is self-directed, with instructor support available. You will then put your learnings to action with an on-site interactive observership at Toronto’s CCRM , a catalyst for commercializing regenerative medicine-based technologies and cell and gene therapies. This micro course is offered in partnership with the University of Toronto Faculty of Applied Science and Engineering, the leading engineering school in Canada.

Within four to six weeks of successfully completing this micro course, you will receive your micro-credential indicating achievement of the outlined learning outcomes and competencies/skills. Micro-credentials are tamper proof, verifiable, blockchain-based and 100% digital. They can be shared on social media, including LinkedIn and Facebook, embedded in websites or downloaded as PDFs.

Learning Outcomes

By the end of this micro course, you'll be able to:

• Describe GMP regulations and their practical application to quality
   
• Identify best practices for working in a GMP compliant environment
   
• Explain the importance of manufacturing control and good documentation practices
   
• Define quality and its relevance in GMP environments
   

Competencies/skills developed in this micro course include: 

• Understanding of GMP
   
• Documentation Practices in Manufacturing
   
• Quality Focus

Notes

Certificate of completion in Upskilling in Biomanufacturing when the following 3 micro courses are completed:

• SCS 4019 Good Laboratory Practice in Biomanufacturing *ON HOLD
• SCS 4023 Quality Assurance Management in Biomanufacturing *ON HOLD
• SCS 4099 Bioprocess Foundations

Eligible learners may apply to the Ontario Student Assistance Program (OSAP) for this micro-credential. You can find more information on our Financial Aid page.