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Overview
Key module objectives
​• Understand the importance of following cGMPs guidelines in the context of the USP, with an emphasis on quality management, traceability and risk analysis​
• Recognize different manufacturing USP techniques and their impact on product, process
and finances, as well as environment​
• Organize the different USP steps and their impact on process & product quality related to people, environment, guidelines / procedures and finances
Target audience
Technicians, operators, supervisors, managers, quality technicians who work in the USP environment
Module Overview
Activity 1: cGMPs and how they apply to the USP for biologics
• What are cGMPs and why they are important, taking into account the specific nature of the manufactured product: biologics Â
• How are cGMPs presented and by whom  Â
• What are the key principles of cGMPs
• What
is USP and how cGMPs apply to USP
Activity 2: Overview of the different USP techniques and main steps of a generic USP in cGMPs for biologics
• USP applies to various biological entities and thus requires different associated processes
• USP at a glance: the main steps of any USP
• Focus on the preliminary phase of USP
• Focus on the amplification phase of USP
• Focus
on the equipment of the amplification phase
• Focus on the closing phase of USP
• Focus on the critical points and controls throughout USP
Activity 3: The USP process 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, essential 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 Essential 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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