Get Support
Overview
Key module objectives
• Recognize and adopt the correct behaviors applied to USP in cGMPs to guarantee the safety of people and environment, and the quality of the product​
• Identify the impacts of non-conform behaviors on product, process and people in USP​
• Adopt the right behaviors related to people, environment and guidelines / procedures at all times
• Adopt the right behaviors and perform complex and at risky actions in USP in cGMPs
Target audience
Engineers, manufacturing managers or supervisor, operators qualified for complex USP operations with analytic skills
Module Overview
Activity 1: Maintaining an aseptic environment for USP in cGMPs
1/ Reminders on contamination, clean rooms and requirements for USP in cGMPs
2/ Focus on controlled environments for USP in cGMPs
Activity 2: Identifying the consequences of risky situations in USP in cGMPs and how to manage them
In this learning element, the participant is asked questions about risky situations and he must identify the consequences of that situation and the actions to be taken, keeping in mind he is always working in pairs. Â
1/ Working
under a biosafety cabinet (BSC)
2/ Performing additive additions and change of medium
3/ Performing open samplings
Activity 3: Appropriate behaviors in USP in practice
In this learning element, the participant put into practice what he has covered in the previous learning elements keeping in mind he is always working in pairs.
1/ Before entering a clean room
2/ Before starting a typical USP manipulation
3/
During the manipulation in a clean room
4/ At the end of the step in a clean room
• Module evaluation quiz
Prerequisites
Complete the modules 1 and 2 of this curriculum, advanced level, or having some knowledge of USP
Learning mode
Remote
Digital modalities
E-learning / 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 3 - Version Master Advanced from 18/11/2022
Accessibility
The courses of this Module meet WCAG standards.
Enroll to this module
How to register to an Immerscio training ?
You are a learner and you would like to access our Immerscio trainning courses? Contact your Immerscio's point of contact within your company or school. If you don't know who your Immerscio point of contact is, don't hesitate to ask us at support@immerscio.com.
You are HR, manager, Training manager and you are interested in Immerscio? To become an Immerscio member and be able to enroll your team or collaborators to Immerscio training, you can directly complete the customer form available here.
Member access is free and not binding. Your membership request will be studied and validated by our teams (delay of 3 days maximum). Once you are an Immerscio member, you can connect to our Customer Portal, browse our training catalog and enroll your learners to the desired trainings.
Process details : Any request to enroll learners to an Immerscio training will need to be validated by the immerscio team (1 week delay maximum). When the enrollment is validated by our team, you will receive a training agreement and must return it signed by all parties involved to be ratified. Once this signed document is returned and reviewed by our teams, the invoice will be sent for immediate payment, and your learners will at the same time receive their access to the subscribed training courses.
For more information on our products, to discuss your ambitions and understand how immerscio could help you meeting them, contact us at support@immerscio.com.