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Overview
Main competencies
Operate all stages of Fill and Finish applying the cGMPs
Pedagogical content
Module 1: Impact of bioproduction on the biotherapy delivery
Module 2: Introduction to Fill & Finish
Module 3: Material reception and handling
Module 4: Thawing/Formulation & Pooling /Filtration
Module 5: Aseptic Filling
line specific conditions
Module 6: Aseptic Filling line: Set up and filling the primary packaging
Module 7: Sampling and control in Fill & Finish
Module 8: Packaging, Labelling, Serialization
Module 9: cGMPs in Fill & Finish
Module 10: Fill & Finish – Applicative module
Module 11: Final evaluation
Target audience
Employee from pharma or chemistry, newcomer to pharma sector, people with interest into pharma sector…
Expertise level
Essential
Prerequisites
Some experience in the health industry or have completed the "Environment of the BioProduction Factory" Essential level course
Learning modes
Remote and face to face (only for the VR)
Evaluation procedures
• 1 Evaluation at the end of each module to be able to access the next module (no limit of attempts, 80% of correct answers required)
• 1 Evaluation at the last module to validate the Curriculum (3 attempts, 80% of correct answers required)
Required equipment
Recommended equipment for an optimal experience : PC computer, with the last version of web browsers Chrome/Firefox/Microsoft Edge, and an internet connection of 8 Mb/s or more. Regarding the virtual reality equipment, please refer to these instructions.
Face to face training
Some activities on this curriculum must be done within an Immerscio Training Center. Please consult the available Immerscio Training Centers and the onsite reservation modalities HERE.
Contact for any question
Curriculum Version & Date
Master Version from 27/03/2023
Accessibility
The courses offered by Immerscio meet WCAG standards with the exception of contents in 3D, in virtual reality or augmented reality. For those contents, alternatives can be proposed to the Trainee. For any questions or additional information, please contact support@immerscio.com.
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