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Overview
Key module objectives
State and implement data traceability
Target audience
Employees from pharma or chemistry, newcomer to pharma sector, people with interest into pharma sector.
Module Overview
Activity 1: Data Integrity for Downstream Process in cGMPs
• Basics of data integrity
• Illustrations of data integrity for DSP
Activity 2: Apply Data Integrity Principles (ALCOA+) for DSP in cGMPs
• 6 use cases on data integrity
Activity 3: Digitalization and Its Impact on Data Integrity
• Handwriting vs. digital data
• Advantages and risks related to increased digitalization
• Module evaluation quiz
Prerequisites
No prerequisites
Learning mode
Remote
Digital modalities
E-learning / Serious Game
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 & Date
Master Version, 15/09/2023
Accessibility
The courses of this Module meet WCAG standards.
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