Skip to main content
alarm Total duration : 120 minute(s)
Catalog price : €750 (VAT excl.), €900 (VAT incl.)

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

support@immerscio.com

Module Version Level & Date

Module 3 - Version Master Essential from 18/11/2022

Accessibility & Disability

The courses of this Module meet WCAG standards.