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Module 2c: Focus on viral safety and molecular biology tests
This module provides an in-depth understanding of the complementary approaches required to ensure viral safety of bioproducts. Learners will discover molecular biology methods, material selection, viral testing, and viral clearance steps. They will be able to apply this knowledge to ensure the safety and compliance of biological products.
Overview
Key module objectives
Ensure viral safety of bioproducts using complementary molecular biology methods and applying viral safety tests at various production stages.
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 : Introduction to viral safety and to molecular ​biology methods
• What is a virus and why is it important to control them?
• Potential sources of viral contamination
• Introduction to molecular biology methods
Activity 2 : The 3 complementary approaches to viral safety
• Material selection to prevent viral contamination
• Direct and indirect viral testing
• Viral clearance steps to remove or inactivate viral contaminants
Activity 3 : Use cases of viral safety tests
• Implementation of viral safety tests at different production stages
• Examples of specific tests for various types of bioproducts
• Testing strategies based on risk analysis
Prerequisites
Second year university level
Or equivalent experience in health industry
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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