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Module 4 : Viral Clearance
Viral safety of biotechnology/recombinant medicinal products. General principle of the "3 pillars of viral safety", potential sources of introduction of viral contaminants, viral clearance steps and viral clearance studies.
Overview
Key module objectives
Understand the origins of the potential viral contamination risk for biotechnology products, and explain the measures implemented in the DSP to ensure the viral safety of the medicinal product.
Target audience
Employees from pharma or chemistry, newcomer to pharma sector, people with interest into pharma sector.
Module Overview
Activity 1: Identification of Viral Clearance steps within the DSP process
• Scope of the module (only applicable to biotechnology/recombinant products)
• The different types of contaminations (conventional viruses and prions).
• The key steps of the production of recombinant products (including USP & DSP).
• The use of viral clearance steps in the DSP for a recombinant product.
Activity 2: Sources of viral risks and the 3 pillars of Viral Safety
• Potential sources of viral contamination.
• Where raw materials of biological origin may be used.
• Measures to mitigate the risk of contamination from the raw materials.
• The three pillars of Viral Safety.
Activity 3: Viral Clearance studies
• The aim of the viral clearance studies (virus validation studies).
• The principles of the viral clearance studies and explain how they are performed.
• How the results of the viral clearance studies are presented.
• Module evaluation quiz
Prerequisites
No prerequisites
Learning mode
Remote
Digital modalities
Activity 1: Serious Game 2D / Activity 2: Serious Game 3D / Activity 3: Serious Game 2D
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 (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.
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 & Date
Master Version, 15/09/2023
Accessibility & Disability
The courses of this Module meet WCAG standards with the exception of contents in 3D. 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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