Course info

On this online course you will learn about the basics of current Good Manufacturing Practice (cGMP) that is followed in pharmaceutical companies.

The course is available both in spring and autumn.

If you wish to take the course, please contact Hongbo Zhang (hongbo.zhang@abo.fi).

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Learning outcomes:
After the completed course, you will 

• understand what the requirements for the quality of pharmaceuticals are and why quality is important
• know the rules and laws (mainly EU-GMP) that control drug production
• know how pharmaceutical quality assurance work is carried out in practice

Course time table: 
The course lasts for ca. 6-7 weeks.

• In spring 2024 the course starts on the 8th of January and finishes on the 1st of March with the final exam at 13-16 (online).
• In autumn 2024 it is possible to complete the course according to your own timetable during 09/09/2024-13/12/2024. The final exam can be taken online on the following dates: 7th October, 11th November or 13th December 2024 at 9-12.   

Study methods: 

Individual studies, learning diary, quizzes, online expert lecture

Study material:

• Eudralex Volume 4
• Lundén Anna, Handbok i GMP (The GMP handbook), Key2Compliance AB
• Other material given on the course’s Moodle page.

Prior knowledge: not required

Study load:
Individual studies 50 h
Exam 3 h
Total: 53 h (2 ECTS)

Examination and grading:

• All online assignments should be completed to pass the course.
• Final exam (online) - max. 30 p. 
• Grading: 
  15 – 17 points = grade 1
  18 – 20 p. = 2
  21 – 24 p. = 3
  25 – 27 p. = 4
  28 – 30 p. = 5