Advanced Therapies GMP Onboarding

This course 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.

Target audience:

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.

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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;
Identify the components of a recognized GMP training program;
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.

	More than 12 hours of interactive training
	Learn at your own pace and in the comfort of your own home
	Test your knowledge through assessments and quizzes
	Pass the exam and obtain your certificate of completion
	Add to your HQP training file for regulatory compliance
	Interact with our experts and network with other trainees

Wondering what Good Manufacturing Practices (GMP) is all about?

Take our Essentials of CGT GMP manufacturing in under 60 minutes course and you’ll have a basic understanding of what manufacturing under GMP means!

At the end of this course, learners will be able to:

Explain how production under GMP differs from routine laboratory work, including process development;
Identify the main components of Quality Management Systems (QMS) required to manufacture biotherapeutics under GMP;
Describe the critical path and steps to translate process development into GMP production: minimizing risk.
This course is also available in French.

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	60 minutes of training
	Learn at your own pace and in the comfort of your own home
	Test your knowledge through assessments and quizzes
	Pass the exam and obtain your certificate of completion

Upcoming training offers

Looking to work in CGT manufacturing or in need of field-specific retraining? Increasing your HQP workforce for your manufacturing facility? Many advanced training offers for various job roles (executives, QA, QC, operators) are in preparation.

Founded in 2014, CellCAN has trained over 250 highly qualified personnel (HQP) and offers unique training on GMP manufacturing throughout Canada. We educate users on why, when and how to engage GMP manufacturing centres in the process of creating a clinical product.

Our network of cell manufacturing facilities (CMF) allows us to tap into world-class expertise, provide unique training opportunities, and offer hands-on learning experiences. CellCAN brings together Canada’s leading experts in regenerative medicine and cell and gene therapy (RMCT) and gives our trainees the opportunity to network with them.

To learn more about our training & make sure you don't miss any opportunities, subscribe to our email list and/or contact us via our Helpdesk.

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About us

CellCAN is a Canadian network focused on advancing cell and gene therapy manufacturing under GMP through the deployment of standards for training that implement best practices.