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Overview
Key module objectives
• Apply data integrity requirement
• Behave and gown properly to come into a cleanroom B/A
Target audience
Employees of the pharmaceutical or chemical industry, newcomers to the pharmaceutical sector, people interested in the pharmaceutical sector…
Module Overview
Activity 1: Data Integrity for Fill and Finish Processes in cGMPs
• As an operator, you will recollect the general principles of data integrity, explain the importance of data integrity and explain the impact or consequences of not fulfilling the data integrity principles in a fill and finish in cGMPs context.
Activity 2: Apply Data Integrity Principles for fill & finish in cGMPs
• As an operator, you will recognize the general ALCOA + principles when confronted with typical situations, apply fill & finish procedures in compliance with data integrity requirements and warn in case of non-compliance and explain the
consequences of not following data integrity principles.
Activity 3: Digitalization and Its Impact on Data Integrity
• As an operator, you will explain the advantages and risks related to the increased digitalization of data in the pharmaceutical industry and follow the right behaviors when using and creating digital data for fill and finish in cGMPs.
Activity 4: Gowning
• As an operator, you will identify the right behavior to limit the risk of contamination for fill & finish in cGMPs and identify the main techniques to monitor contamination in a cleanroom.
Activity 5: Behavior
• As an operator, you will recognize the importance of appropriate behaviors when working with biologics, identify and list the main sources of contamination and adopt the right behaviors to avoid them in fill and finish in cGMPs, list the
different types of clean rooms and their main differences, recall the actions, purpose and impact of working aseptically during key steps of the fill & finish.
• Module evaluation quiz
Prerequisites
Previous modules validated or knowledge already acquired
Learning mode
Remote
Digital modalities
elearning/Serious Game 3D / 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. Regarding the virtual reality equipment, please refer to these instructions.
Face to face training
Not Applicable
Contact for any question
Module Version Level & Date
Master Version from 27/03/2023
Accessibility
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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