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Overview
Key module objectives
To put in practice and apply the content covered in modules 1, 2 and 3 (Introduction to data integrity, Data Integrity: How to contribute to its implementation? Computerized systems validation: a mandatory condition for Data Integrity).
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 Part 1: Regulatory inspection: real-life situations
• What is an inspection?
Activity #1 Part 2: Regulatory inspection: real-life situations
• Inspection related to Data Integrity strategy
Activty #2: Data Integrity: key messages
• Uncontrolled form
• Access, Time and Data Management
• Audit Trail review in QC
• Line Clearance inspection
Activity #3: Use cases: real-life scenarios of regulatory inspection
• Inspection related to logistics and distribution
• Inspection related to research and development
• Inspection related to clinical trials
• Inspection related to validation
Prerequisites
Possess the competencies from Modules 1, 2 and 3
Learning mode
Remote
Digital modalities
Activity 1 Part 1: E Learning / Activity 1 Part 2: Serious Game 3D / Activity 2: Serious Game 3D / 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
N/A
Contact for any question
Module Version Level & Date
Advanced level, Gold Version from 25/06/2024
Accessibility & Disability
The courses of this Module meet WCAG standards with the exception of contents in 3D. For those contents, alternatives can be proposed to the Trainee. For any questions or additional information, please contact support@immerscio.com.
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