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Overview
Key module objectives
Implement the right behaviors to guarantee people and environment safety, and the quality of the product in DSP in cGMPs
Target audience
Technicians, operators, supervisors, managers, quality technicians who work in the USP environment
Module Overview
Activity 1: Recognizing the importance of behaviors in DSP in cGMPs
1/ Overview of the importance of a controlled environment for bioproduction
2/ Overview of contamination, its sources, vectors and consequences
3/ Types of clean rooms
Activity 2: Adopt the right behaviors to reduce the risks of contamination in DSP in cGMPs
1/ Staff contamination
• Hand washing
• Gowning
• Putting on gloves
• Accreditation
• Movements and behaviors
2/ Environment contamination
3/ Equipment and work surfaces contamination
4/ Contamination monitoring
• Air monitoring
• Surface monitoring
• Garments & gloves monitoring
• Good sampling practices
Activity 3: Recognizing and adopting the right behaviors for DSP in cGMPs
In this learning element, the participant will put into practice what he has covered in the previous learning elements.
1/ Before entering a cleanroom
2/ Working in a clean room
3/ Before leaving a clean room
• Module evaluation quiz
Prerequisites
No prerequisites
Learning mode
Remote
Digital modalities
Gamified e-learning / 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
Not Applicable
Contact for any question
Module Version Level & Date
Master Version, 15/09/2023
Accessibility
The courses of this Module meet WCAG standards.
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