13 November 2023

QA QC GXP for Pharmaceutical Production

Obtain a broad overview of connections between all stages in the development process of a drug product with focus on the GXP areas.

QA QC GXP for Pharmaceutical Production

This course is for you having an academic background with little or no knowledge of the different stages of the quality within development of a drug product. You will gain a broad overview of connections between all stages in the development process of a drug product with focus on the GXP areas, i.e. Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice and Good Distribution Practice.

The course is relevant for you aiming to gain a basic knowledge of the law / guidelines relevant for working in a GXP environment. Also, you will be able to see the link between the different areas of work, ex. activities related to testing in animals and in humans, pharmacovigilance, manufacturing and transportation of the drug product. You will experience that some of the laws / guidelines are quite similar between the different GXP areas, but varying in the focus and the way how they are interpreted.














By attending this course you will be able to:

  • Understand the reason for a need to work with Quality Control (QC) and Quality Assurance (QA) within the different GXP areas
  • Understand the complexity of working with different GXP laws / guidelines
  • Understand how the GXP laws / guidelines are implemented within the company
  • Learn the tools to continue to be in compliance with the GXP laws / guidelines
  • Achieve an overview on how a drug is tested in animals, in humans, formulated as the final drug product and finally, challenges related to the transportation of the drug product  in a controlled way (for the human study and to the final consumer)








































Course details

Duration: 5 days on campus
Dates: 13-17 November 2023
Frequency: Only available every second year
Place: University of Copenhagen, Copenhagen, Denmark
Course fee: EU/EEA citizens: 10,750
Non-EU/EEA citizens: 12,543 DKK

The fee includes lunch/coffee.

Payment conditions

Level and credit: Master's course; 2,5 ECTS
Examination date: Announced in the winter 2023/2024 exam plan
Application deadline: 8 weeks prior to course start

To be admitted, you must meet the admission criteria for Master of Industrial Drug Development

Course dates and application deadlines are announced via the  programme newsletter.
Download course curriculum