This course is designed for cell biologists, research scientists, process engineers, quality assurance specialists, technologists and trainees (and other end users) who are working, or plan to work in areas associated with the manufacturing of cell and gene therapies, or want to expand their knowledge on advancing cell and gene therapy projects towards the clinic.
At the end of this course, 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.
This course is recognized by NGen AmpUp program, which covers 50% of training costs for employees of NGen member companies! To see if you are eligible for these substantial savings, enquire with your employer.*
For full details, visit www.ngen.ca/upskilling.