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Module 3c: Applicative module: viral safety and molecular biology tests
This module covers manufacturing and in-process controls for recombinant bioproducts and vaccines. It also addresses sample management and the manufacturer’s responsibilities for test quality. Learners will gain skills to apply testing strategies and manage samples throughout the production process.
Overview
Key module objectives
Understand and apply manufacturing and in-process controls (IPC) to ensure the quality of bioproducts, focusing on recombinant bioproducts and vaccines.
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.
Module Overview
Activity 1 : Manufacturing and In-Process Controls for bioproducts​ - Application to recombinant bioproducts​
• Regulatory framework and viral safety
• Manufacturing process of recombinant bioproducts
• Principles and testing strategy during manufacturing
Activity 2 : Manufacturing and In-Process controls for bioproducts​ -Specific case of vaccines
• Regulatory requirements specific to vaccines
• Manufacturing process of an inactivated viral vaccine
• Application of testing strategy for viral vaccines
Activity 3 : Sample management and key responsibilities of the manufacturer for the tests quality
• General principles regarding samples
• Life cycle of samples
• Inactivation control tests for inactivated viral vaccines
Prerequisites
Second year university level
Or equivalent experience in health industry
Completion of the previous module in the same domain.
Learning mode
Remote
Digital modalities
e-learning
Evaluation procedures
• A short evaluation at the end of the module confirming what you have learnt and enabling you to move to the next one (no limit of attempts, 80% of correct answers required).
• Trainees enrolled in the whole curriculum have the possibility to assess and set their new knowledges and skills via an anchoring quiz between modules.
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.
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
Module Version Level & Date
Master version from 25/07/2024
Accessibility & Disability
The courses of this Module meet WCAG standards with the exception of contents in 3D/VR/AR. 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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