4023 - Quality Assurance Management 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 vaccines and  therapies to patients, both in the clinical trial phases and once products are approved.

A core component of GMP manufacturing is an organization’s quality assurance (QA) management program, which provides and maintains quality systems to assure compliance with phase-appropriate GMP requirements. A QA team carries out key processes, such as document control and GMP training, and oversees validation.

This two-part micro-course provides a thorough overview of QA management in biomanufacturing. As the industry faces a training gap, there is demand for qualified, skilled workers to operate GMP-compliant facilities, and perform critically important QA management. The completion of the Upskilling in Biomanufacturing Program helps to address this training gap. Completing this micro-course 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 required skills.

In this course, you will apply key concepts including data analysis, problem diagnosis, Corrective and Preventive Actions (CAPA) and Statistical Process Control (SPC). The first part of the micro course is self-directed, with instructor support available, and you’ll explore leading methodologies such as ISO, Total Quality Management, Lean and Six Sigma, and learn how to apply them to manage product quality.

In the second part of the micro course, you will 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 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:

• Identify and describe leading quality models and process excellence methodologies including ISO, TQM, Lean and Six Sigma.
• Explain the impact of quality on business results
• Analyze data in order to diagnose quality issues and determine root causes
• Describe and follow the 7-step process for Corrective and Preventive Action (CAPA)
• Describe and follow recommended control strategies and tools including Statistical Process Control (SPC) and Standard Operating Procedures (SOP)

Competencies/skills developed in this micro course include:
Understanding Quality Models 
Quality Focus 
Data Analysis of Quality Issue

Notes

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

• SCS 4023 Quality Assurance Management in Biomanufacturing *ON HOLD
• SCS 4019 Good Manufacturing Practice 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.