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alarm Total duration : 105 minute(s)
Catalog price : €750 (VAT excl.), €900 (VAT incl.)

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

support@immerscio.com

Module Version Level, Date & Price

Master Version, 15/09/2023
€750

Accessibility & Disability

The courses of this Module meet WCAG standards.