This Course is For You If;
And..
Enroll in this course to learn…
- Key manufacturing technologies – such as organic chemical synthesis, biopharmaceutical manufacturing, tablet manufacturing and aseptic & sterile manufacturing
- Purified water generation – storage and distribution that underpin aseptic/sterile processing
- Clean steam – water for injection, storage and distribution that underpin aseptic/sterile processing.
- Instrumentation process control design – for the generation and distribution of clean utility systems.
- Cleanroom layout design – layout and classification along with the environmental controls pressure profiles
- Aseptic processing – lyophilization and how vials are filled in an aseptic environment
- Quality systems – for cleanrooms for both EMA and FDA guidance on aseptic processing.
You’ll produce a number of deliverables throughout the program including…
- Complete 8-question booklets (one for every week’s worth of content) which will summarise what you have learnt for the week and ensure you retain and understand the information.
- Complete an end of module assignment to include the following:
- Sketch and label process flow diagrams illustrating typical biopharmaceutical unit operations for the sequential manufacture of both drug substances and drug products.
- Describe process support and utility systems encountered on a typical biopharmaceutical facility
- Sketch and describe the configuration of a hypothetical cleanroom environment for aseptic processing (e.g. for vial filling operations).
- Describe the similarities and differences between pharmacopoeia grade purified water (PUW) and water for injection (WFI).
And take the following skills and knowledge back to work…
- You’ll have a strong foundation in how safe medicines and medical devices are made in a GMP regulated manufacturing environment.
- You’ll understand the air, clean water and steam systems that underpin aseptic/sterile processing.
- You’ll understand cleanroom layout design, layout and classification and the environmental controls pressure profiles
- You’ll have the technical knowledge and understanding of the quality culture necessary to work in this environment
Course Price
Entry Requirements
- You have worked in a GMP Regulated Pharmaceutical or Medical Device manufacturing environment.
Hear From People Who’ve Taken This Course
John Ryan
“The course content material is concise and interesting”
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