GDP Responsible Person

Type product
Tijdsduur
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Beschrijving

The Good Distribution Practice guideline, also known as the GDP guideline, stipulates that all employees who work with medicines must receive regular training. A distinction is made between a Responsible Person and logistics employees.

The complete Responsible Person training consists of the logistics employee module and the additional Responsible Person module.

The content of this training meets the Guidelines GDP dated 5-11-2013 (2013 / C343 / 01) and GDP API dated 19-3-2015 (2015 / C95 / 01).

The training lasts 2 half days. This includes a knowledge test and (after answering enough questions correctly) a (digital) certificate.

In this module, an employee learns:

  • basic knowledge of …

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The Good Distribution Practice guideline, also known as the GDP guideline, stipulates that all employees who work with medicines must receive regular training. A distinction is made between a Responsible Person and logistics employees.

The complete Responsible Person training consists of the logistics employee module and the additional Responsible Person module.

The content of this training meets the Guidelines GDP dated 5-11-2013 (2013 / C343 / 01) and GDP API dated 19-3-2015 (2015 / C95 / 01).

The training lasts 2 half days. This includes a knowledge test and (after answering enough questions correctly) a (digital) certificate.

In this module, an employee learns:

  • basic knowledge of medicines (incl. serialization and handling counterfeits);
  • the purpose of the GDP directive;
  • which legislation and permits apply;
  • what his / her responsibilities are;
  • how suppliers and customers should be assessed; what are requirements for storage, transport and equipment (including mapping, validation, outsourced activities);
  • how the quality management system can be managed (incl. controls, deviations, CAPA and document management);
  • how to deal with complaints, returns, recalls and quarantine.
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