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Total duration : 15 hour(s)
Catalog price : €6600 (VAT excl.), €7920 (VAT incl.)
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
Operators, technicians, production managers, continuous improvement and performance managers, engineering managers, maintenance staff, or project managers in the pharmaceutical, chemical, or biotechnology sectors.
Collaborators joining or working at the interface of a bioproduction unit.
Quality Assurance or Quality Control personnel operating in bioproduction.
Students in life sciences, pharmacy, or chemistry, or individuals from academic backgrounds seeking to understand the industrial environment of the pharmaceutical formulation of biomedicines (Fill & Finish).
Expertise level
Essential
Prerequisites
Scientific background, initial experience (> 1 year) in bioindustries, chemistry, pharmacy, or equivalent in conducting or supervising manufacturing or quality control operations in the healthcare industry. Alternatively, prior completion of the P1 introductory course on the bioproduction plant environment is recommended.
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 & Disability
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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