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Overview
Key module objectives
State and implement data traceability
Target audience
Engineers, manufacturing managers or supervisor, operators qualified for complex DSP operations with analytic skills
Module Overview
Activity 1: Examine Data Integrity For Downstream Process in cGMPs
• Data Integrity, principles and stakes
• Acting on Data Integrity gaps
Activity 2: Identify and resolve Data Integrity gaps during DSP in cGMPs
• Use Case 1&2: Identify data integrity gaps
• Use Case 3: Apply the investigation and CAPA model to a real-life example
Activity 3: Anticipate the growing digitalization and its impacts on Data Integrity
• Digitalization : advantages, challenges and regulatory requirements
• Do’s and don'ts
• Module evaluation quiz
Prerequisites
 Complete previous modules of this curriculum, advanced level, or having knowledge of DSP
Learning mode
Remote
Digital modalities
E-learning / Serious Game
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 (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 & Price
Master Version, 15/09/2023
€750
Accessibility & Disability
The courses of this Module meet WCAG standards.
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