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Overview
Main competencies
Master efficacy and potency assays of bioproducts.
Understand microbiological tests and global workflow.
Apply quality controls during manufacturing.
Manage unexpected results and deviations.
Ensure data integrity in quality control.
Pedagogical content
Module 1: Overview of Quality Control
Module 2a: Focus on Microbiology
Module 3a: Applicative module: microbiological tests
Module 2b: Focus on Physico-chemistry and Immunology
Module 3b: Applicative module: physicochemical test and immunoassay
Module 2c: Focus on viral safety and molecular biology tests
Module 3c: Applicative module: viral safety and molecular biology tests
Module 4: Validation of analytical methods
Module 5: In vitro, in vivo and ex vivo efficacy tests
Module 6: Analytical methods: use cases
Module 7: Final evaluation
Target audience
• Collaborators integrating or working in interface with a bioproduction or quality control unit (Technicians and managers of quality control laboratories, operators, and technicians of production areas).
• Support functions in laboratories (maintenance, Quality Assurance, R&D).
• Partners (suppliers, service providers, subcontractors) operating in bioproduction or quality control partners.
• Students in life sciences, analysis and control, pharmacy or chemistry, or individuals from the academic field wishing to understand the industrial environment of biopharmaceutical control.
Expertise level
Not Applicable
Prerequisites
• Initial scientific training, initial experience in bioindustries, chemistry, pharmacy, or equivalent in conducting or supervising manufacturing or quality control operations in the health industry.
• If required, having previously completed the P1 introductory curriculum to the bioproduction plant environment.
Learning mode
Blended Mode (remote for all modules except modules 2a and 3a activity 3 in 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.Â
Contact for any question
Curriculum Version & Date
Master version from 25/07/2024
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.
Enroll to this curriculum
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