​General Course Learning Objective: To refresh and apply the knowledge about correcting documents following the Good Documentation Practice (GDocP).

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Module 4 Learning Objective: To identify how to correct Pharma documentation following the GDocP regulations.

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Learners’ needs: To be able to correct documents as per the GDocP

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Problem that this course aims to solve: Given that this is an annual refresher training, where the content may be repetitive and extensive, the course divides the content into short modules (micro-learning). Interactive activities use real examples from employees’ day-to-day work. The short length of the modules allows for independent learning within the course, and also facilitates the introduction of new features and activities in future editions.

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Target audience: Employees in the Pharma industry.

 

Expository Method: Drag & drop activity that allows learners to identify correct and incorrect ways of amending documentation. The activity provides immediate feedback to learners.

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Learning Theories: Knowles Andragogy, Elements of Strategic Design (Vignati), Learning Design Effectiveness (Polymenakou).

 

Learning Models: ADDIE, Backwards Design, Design Thinking from Stanford.

 

Software: Articulate Storyline, Canva, Procreate.

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Content Source: Eudralex. EU Guidelines to Good Manufacturing Practice in Medicinal Products for Human and Veterinary Use.