STREAM: GMP Foundations & Manufacturing Techniques
The technical baseline required to work under Good Manufacturing Practices (GMP), covering documentation, aseptic processing and environmental monitoring.
Learning Objectives:
- Apply GMP principles and the advanced therapies regulatory landscape to a manufacturing setting
- Produce and maintain compliant documentation under Good Documentation Practices
- Understand the theory of aseptic processing and correct biosafety cabinet technique
- Interpret environmental monitoring data and recognise excursions requiring action
Modules:
- Introduction to Good Manufacturing Practices
- Introduction to the Regulatory Landscape for CGT
- Introduction to Good Documentation Practices
- Introduction to Aseptic Processing
- Working in a Biosafety Cabinet
- Fundamentals of Environmental Monitoring
EST. COMPLETION 2.75 HRS - E-LEARNING FORMAT