GDP Pharma supply chain responsible person

Specifications

 Type: classroom

 Duration: 16 hours

 Language : NL - EN

 Proof: Certificate from our academy (after successfully completing the exam)



PLEASE NOTE: Our certificates are valid for 2 years. You must have completed your training again before the expiry date.

classroom training schedule

Objective


Pharmaceutical companies operating in Europe must comply with GDP requirements to comply with both local and EU regulations.

Pharmaceutical companies outside Europe can also work according to the EU GDP guidelines and apply this Good Distribution Practice. Investing in high-quality GDP training not only ensures compliance with these regulations, but also builds trust with customers and regulators.

By paying attention to essential elements such as contamination prevention and proper storage, companies can ensure the quality of their products and protect public health.


Within the pharmaceutical supply chain, the role of a Responsible Person (RP) is crucial. Comprehensive Responsible Person training provides professionals with the skills and knowledge to become a Responsible Person according to guidelines.

Our GDP training certificates (for the RP), combined with relevant experience, enable you to become a Responsible Person.


Our GDP training for the Responsible Person covers a wide range of essential topics, including Good Distribution Practice (GDP) compliance, risk management, quality assurance and the proper handling of pharmaceutical products.

Participants will learn to identify and mitigate potential risks in the supply chain so that products are stored and transported under optimal conditions to maintain their quality and effectiveness.

In addition, the Responsible Person training emphasizes the legal responsibilities of a Responsible Person, which are crucial to preventing regulatory breaches and ensuring operational continuity.


With the ever-changing regulatory environment in the pharmaceutical industry, the role of the Responsible Person has become increasingly complex. Effective training ensures that RPs remain up to date with regulatory changes, including new legislation and guidance from health authorities.

This strengthens the overall security of the pharmaceutical supply chain by ensuring that all products, from raw materials to finished medication, meet strict compliance standards.


Another important aspect of Responsible Person training is the emphasis on safety protocols. The health and well-being of patients depend on the proper handling, storage and transportation of pharmaceutical products. GDP training programs provide an in-depth understanding of the potential hazards in these processes and teach Responsible Persons how to take preventative measures to avoid contamination, mismanagement or delays in product delivery.

This ensures that products comply with regulations and reach patients in their intended form, while ensuring product safety, efficacy and quality, and maintaining public confidence.


By completing a Responsible Person training course at our academy, current and future Responsible Persons are better equipped to ensure their organizations meet the highest regulatory standards.

This ultimately protects public health and contributes to a safer and more efficient pharmaceutical supply chain.

Target audience

Quality managers, operations coordinators and transport managers



Experience

Basic knowledge of GDP guidelines required.

Please consult our training offer for the appropriate training.




Contents

  • Explanation of how to comply with the guidelines in your work environment
  • What and why QRM?
  • How to comply with GDP guidelines in your business.
  • Components of a good CAPA process
  • Risk assessment, Risk control, Risk communicatie en Risk review
  • What to do as an RP in a company
  • Implementation within the QMS with practical exercises
  • Exam (80% minimum result) this training

Result

  • The ability to explain, implement, improve and safeguard GDP laws and regulations within your own organisation.
  • The ability to carry out the RP's responsibilities in accordance with guidelines
  • The ability to perform quality control and identify product quality and compliance risks, and improve the QMS accordingly.
  • Practical exercises
  • Continuous improvement of your processes (focus pharma)
  • Certificate from our academy (after successfully completing the exam)



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