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Overview
Key module objectives
Explain main cGMPs guidelines and what it means for USP, explain the main steps of a USP process and their impact.
Target audience
Engineers, manufacturing managers or supervisor, operators qualified for complex USP operations with analytic skills
Module Overview
Activity 1: cGMPs and how they apply to Upstream processes (USP)
• Reminders of the main cGMPs guidelines
• Reminders of the main goals of cGMPs, specific risks related to biologics, and implications of a globalized industry
• Brief overview of USP process and what it applies to
Activity 2: USP in cGMPs processes in detail for biologics
• Focus on the anticipation of the preliminary steps of USP in cGMPs
• Focus on the amplification phase of USP, with a focus on complex procedures and details on equipment
• Focus on the closing phase of USP
• Focus on the critical
points and controls throughout USP, including data analytics
Activity 3: USP in cGMPs in practice
• Applicative exercises and games to put into practice the knowledge from the previous learning elements.
• Module evaluation quiz
Prerequisites
Complete the module 1 of this curriculum, advanced level
Learning mode
Remote
Digital modalities
E-learning / immersive 360° / Serious Game
Evaluation procedures
• A final evaluation at the last module to assess what you have learnt in the curriculum (max. 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
Not Applicable
Contact for any question
Module Version Level & Date
Module 2 - Version Master Advanced from 18/11/2022
Accessibility
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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