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Online training course: Good Distribution Practice according to the European Union Guidelines (EU GDP)

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Good distribution practice is one of the important factors in manufacturing quality, effective, and safe medicinal products. Good distribution practice principles must be taken into account in the overall management of the supply chain, thus preventing the entry of falsified medicinal products into the supply chain.

Aim

The e-training will provide you with an overview of the requirements of good distribution practice according to the European Union guidelines for the distribution of medicinal products and active substances for human use. At the end of the training, you will take an exam to reinforce your understanding of those requirements. The training is therefore particularly recommended for new employees or employees starting their careers.

Content

  • Introduction to good distribution practice
  • Basic requirements of good distribution practice (quality system, personnel, premises, and equipment, documentation, procedures, complaints, returns, recalls, outsourced activities, internal audits, transport, provisions for brokers)
  • Principles of good distribution practice for active pharmaceutical ingredients
  • Discussion of practical examples
  • Summary of the content presented
  • Written exam

Work method 

  • The e-training will take place in a live virtual classroom.
  • You will receive a link to the online training up to two days before the event.
  • To participate in the online training, you will need a computer with a microphone and camera and a reliable internet connection.

Target group

  • Manufacturers of medicinal products for human use.
  • Distributors of medicinal products and active substances for human use.
  • Quality management system auditors and consultants.

Course and materials will be in English language.

The online workshop will take place in a live online e-classroom and will be divided into three parts with breaks in between.  Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.

Additional information: Bojan Varga, phone: +386 1 477 81 08, e-mail: bojan.varga@siq.si

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