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Overview
Key module objectives
• Understand the importance to continuously track & trace controls all along the manufacturing process ​
• Identify Data Integrity principles and actions related to USP in cGMPs
• Recognize representative Data Integrity actions related
to USP in cGMPs​
• Classify different representative data integrity actions related to USP in cGMPs: action on deviation and CAPA follow up​
Target audience
Technicians, operators, supervisors, managers, quality technicians who work in the USP environment
Module Overview
Activity 1: Data Integrity for Upstream Processes in cGMPs
• Define Data, data integrity and data lifecycle
• Understand the stakes of Data Integrity
• Introduce Data integrity principles: ALCOA+
• Illustrate ALCOA+ principles for USP
Activity 2: Apply Data Integrity Principles (ALCOA+) for USP in cGMPs
• Solve simple use cases involving Data Integrity issues during USP
Activity 3: Digitalization and Its Impact on Data Integrity
• Understand the impacts of digitalization on Data Integrity
• Adapt one’s behaviors
• Module evaluation quiz
Prerequisites
Complete the modules 1, 2 and 4 of this curriculum, essential level, or have 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 5 - Version Master Essential from 18/11/2022
Accessibility
The courses of this Module meet WCAG standards.
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