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Overview
Key module objectives
• Order data life cycle steps
• Define ALCOA+ (ALCOA = Attributable, Legible, Contemporaneous, Original, and Accurate ; + = Complete, Consistent, Enduring and Available)
• Identify and correct bad practices of data collection regarding
ALCOA+ compliance
Target audience
Employee from pharma or chemistry, newcomer to pharma sector, people with interest into pharma sector…
Module Overview
Activity 1: Basics of Data Integrity
• Basics of Data Integrity in the BioProduction Environment
• What do we mean by “data” & "data integity"?
• Data Integrity as a part of Good Manufacturing Practices (GMP)
• Data integrity in US & Europe regulation
• Data integrity from GMP point of view
• Manual vs electronic & Illustrated examples of manual data entries
Activity 2: Data in the BioProduction environment
Présentation of the data life cycle stages; Advanced data integrity principles (AlCOA+)
Activity 3: Good and bad data integrity practices in the work environment
On-the-job scenario to apply a mix of ALCOA+ principles
• Module evaluation quiz
Prerequisites
Complete the modules 1, 2, 3 and 4 of this curriculum, advanced level, or having some basic knowledge of the BioProduction environment
Learning mode
Remote
Digital modalities
Gamified elearning / Serious Game 2D
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 Advanced from 18/11/2022
Accessibility
The courses of this Module meet WCAG standards.
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