Get Support
Overview
Key module objectives
• Understand the importance to continuously track & trace controls all along the manufacturing process
• Identify Data Integrity principles and actions related to USP in cGMPs
• Recognize representative Data Integrity actions related to USP in cGMPs
• Classify different representative data integrity actions related to USP in cGMPs: action on deviation and CAPA follow up​
• Identify Data Integrity gaps within USP in cGMPs, perform investigations and carry out corrective and preventive actions in coordination with all concerned actors
Target audience
Engineers, manufacturing managers or supervisor, operators qualified for complex USP operations with analytic skills
Module Overview
Activity 1: Examine Data Integrity For Upstream Processes in cGMPs
• Understand expectations regarding data integrity: why it’s important, what are ALCOA+ principles
• Investigate and solve Data Integrity gaps: a general method
Activity 2: Identify and resolve Data Integrity gaps during USP in cGMPs
• Use cases 1&2: identify gaps regarding Data integrity
• Use case 3: apply investigation and CAPA model to a real-life example
Activity 3: Anticipate the growing digitalization and its impacts on Data Integrity
• Understand advantages and risks with digitalization
• Understand and act on 21 CFR FDA Part 11 requirements
• Recognize non-compliant behaviors regarding electronic data
• Key questions to make sure electronic data is compliant
with Data Integrity requirements
• Module evaluation quiz
Prerequisites
Complete the modules 1, 2 and 4 of this curriculum, advanced level, or having knowledge of USP
Understand the in-line process control principle
Learning mode
Remote
Digital modalities
E-learning / Serious Game
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.
Enroll to this module
How to register to an Immerscio training ?
You are a learner and you would like to access our Immerscio trainning courses? Contact your Immerscio's point of contact within your company or school. If you don't know who your Immerscio point of contact is, don't hesitate to ask us at support@immerscio.com.
You are HR, manager, Training manager and you are interested in Immerscio? To become an Immerscio member and be able to enroll your team or collaborators to Immerscio training, you can directly complete the customer form available here.
Member access is free and not binding. Your membership request will be studied and validated by our teams (delay of 3 days maximum). Once you are an Immerscio member, you can connect to our Customer Portal, browse our training catalog and enroll your learners to the desired trainings.
Process details : Any request to enroll learners to an Immerscio training will need to be validated by the immerscio team (1 week delay maximum). When the enrollment is validated by our team, you will receive a training agreement and must return it signed by all parties involved to be ratified. Once this signed document is returned and reviewed by our teams, the invoice will be sent for immediate payment, and your learners will at the same time receive their access to the subscribed training courses.
For more information on our products, to discuss your ambitions and understand how immerscio could help you meeting them, contact us at support@immerscio.com.