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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
Target audience
Technicians, operators, supervisors, managers, quality technicians who work in the USP environment
Module Overview
Activity 1: Recognizing the importance of behaviors in USP in cGMPs
1/ Overview of the importance of a controlled environment for bioproduction
2/ Defining contamination, its sources and vectors
3/ Differentiating different types of clean rooms
Activity 2: Adopt the right behaviors to reduce the risks of contamination for USP in cGMPs
1/ Contaminations related to the staff
•   Hygiene
•   Gowning
•   Focus on the gowning differences between clean rooms
•   Movements
2/ Contaminations related
to the environment
3/ Contaminations related to the equipment and work surfaces
4/ Monitoring of the possible sources of contamination
• Air monitoring
• Surface monitoring
• Garments & gloves monitoring
• Good sampling
practices
Activity 3: Recognizing and applying the right behaviors for USP in cGMPs
In this learning element, the participant will put into practice what he has covered in the previous learning elements.
1/ When entering in a clean room
2/ Working in a clean room
3/ Before leaving a clean room
• Module evaluation quiz
Prerequisites
Complete the modules 1 and 2 of this curriculum, essential level, or having some basic 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 Essential from 18/11/2022
Accessibility
The courses of this Module meet WCAG standards.
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