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Overview
Key module objectives
• Define data integrity
• Identify the stakes of data integrity in the bioproduction environment
• Identify the components of a data
• Define what is an ALCOA data and what it implies in terms of recording
• 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
• Components of a data
• Data, metadata (definitions & examples)
• Lifecycle as a part of the data (short introduction)
• The principles of data integrity / ALCOA
• The importance of data integrity
• Explanation of the
ALCOA concept (concepts and examples)
Activity 3: Good and bad data integrity practices in the work environment
Identifying data integrity breaches and undertaking corrective actions to prevent the breach
• Module evaluation quiz
Prerequisites
Complete the modules 1, 2, 3 and 4 of this curriculum, essential 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 Essential from 18/11/2022
Accessibility & Disability
The courses of this Module meet WCAG standards.
Enroll to this module
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