Course An introduction to Good Manufacturing Practice (GMP)

ECTS: 1.2

Course leader: Dirk Bender

Language: English

Graduate school: Faculty of Health

Graduate program: ClinFO

Course fee: 1,440.00 DKK

Status: Course is open for application

Semester: Fall 2023

Application deadline: 24/08/2023

Start date: 21/09/2023

Administrator: Lena Melchior Villadsen

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