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Overview
Key module objectives
Explain the link between Data Integrity and batch release.
Target audience
Employees or newcomers in pharmaceutical or chemistry or biotechnolgies industries
Operators, techniciens and Managers from production areas and IT support
Technicians and Managers from Quality Control laboratories
Quality Assurance personnels
Module Overview
Activity #1: Data Integrity applied to products release
• The process of a new drug development
• The process of batch release
Activity #2: Data Integrity: from source data to batch release
• Regulatory requirements for batch release
• Link between data and batch release
• Importance of data in a batch recall situation
Activity #3: Data Integrity: good practices for products release
• An operator and his manager after a data input error is identified
• An IT Administrator facing technical operation choices during a user request
• An operator sees a data loss disrupting batch compliance
• A QA Specialist sees a deviation during a review of the DSP batch file
Prerequisites
No prerequisites
Learning mode
Remote
Digital modalities
Activity 1: E Learning / Activity 2: Serious Game 2D / Activity 3: Serious Game 3D
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 (no limit of attempts, 80% of correct answers required).
• Trainees enrolled in the whole curriculum have the possibility to assess and set their new knowledges and skills via an anchoring quiz between modules."
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
Some activities on this curriculum must be done within an Immerscio Training Center. Please consult the available Immerscio Training Centers and the onsite reservation modalities HERE.
Contact for any question
Module Version Level & Date
Advanced level, Gold Version from 28/06/2024
Accessibility & Disability
The courses of this Module meet WCAG standards.
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