Course An introduction to Good Manufacturing Practice (GMP)

The course, C254/08 An introduction to Good Manufacturing Practice (GMP), is being offered by the Graduate School of Health, Aarhus University, 2023.

Criteria for participation: University degree in medicine, dentistry, nursing, or Master’s degree in other fields and/or postgraduate research fellows (PhD students and research-year medical students). 

Recommended knowledge for participation: The course addresses participants without or only very limited knowledge of GMP.

Aim: To introduce PhD students at Health, Aarhus University to the basic terms and principles of GMP controlled manufacture of pharmaceutical products

Learning outcome: 

• Be familiar with basic principles and terms of GMP and its impact in Danish legislation
• Be able to understand specific challenges arising from GMP
• Know where to seek advice concerning further development of GMP skills

Workload: The full workload of the course is expected to be 30,25 hours.

Content: Introduction to the historic development of GMP

• GxP, GMP, EU GMP, US GMP, WHO GMP, PIC/S What is this?
• Introduction to most relevant EU-GMP guidelines
• GMP Interpretation in Industry, Public Service Institutions, and at Authorities
• GMP case study

Instructors: Dirk Bender and external instructors

Venue: Aarhus University, Aarhus

Participation in the course is without cost for:

• PhD students, Health Research Year students and Health Research Honours Programme students from Aarhus University
• PhD students enrolled at partner universities of the Nordoc collaboration
• PhD students from other institutions in the open market agreement for PhD courses

Course dates:

• 21 September 2023 08:30 - 16:00
• 28 September 2023 08:30 - 16:00
• 05 October 2023 08:30 - 16:00