This learning path is designed to maximize the efficiency of knowledge uptake and retention covering the theory component of an onboarding curriculum for biomanufacturing under GMP in under 20 hours.
Those working in bioprocessing (including manufacturing and process development), cell biologists, research scientists, cleanroom operators, process engineers, quality roles and regulatory specialists, technologists and trainees (and other end users) who are working, or plan to work in biomanufacturing of advanced therapies, including cell and gene therapies and vaccine production will benefit from this training. Individuals wanting to expand their knowledge on translating cell and gene therapy projects into clinical production, or participants working in supply chain and logistics within the sector will benefit as well.
At the end of this learning path, the participants will be able to:
- Identify the essentials of GMP requirements and the relevant Canadian and international regulations;
- Identify cleanroom facility and gowning requirements and define aseptic workflow;
- Recall the main components of a Quality Management Systems (QMS), including SOP writing and quality manual development, batch records, environmental monitoring and GMP training program;
- Describe how to plan a validation strategy through Quality by Design and risk management;
- Explain basic manufacturing techniques for cell-based therapies;
- Identify the quality control steps and parameters required for product release.