Designed for researchers, scientists, biomanufacturing professionals and trainees seeking to build foundational knowledge of GMP requirements, cleanroom operations, quality management systems, validation strategies and manufacturing processes for cell-based therapies, including quality control and product release.
Learning Objectives:
- 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.
Included Courses:
- GMP - Foundational Knowledge & Biocontainment
- Planning to meet GMP requirements globally
- Foundations of Quality Management Systems (QMS)
- Good Documentation Practices - SOPs and Batch Records
- Planning a Validation Strategy - Intro to Quality by Design
- Risk Management
- Quality Control and Product Release
- Case Study - Reagent Selection: Using the appropriate grade of products
- Case Study - Translation of cell therapies into clinical production