Kurssin kuvaus

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

Completing the course will give you 2 ECTS credits. The course is held two times a year, both in spring and autumn. If you wish to take the course in spring, please contact Hongbo Zhang (hongbo.zhang@abo.fi) or if in the autumn, please contact Outi Salo-Ahen (osalo@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 EU-GMP principles that control drug production
• understand how pharmaceutical quality assurance work is carried out in practice

Course time table: 
The course lasts for ca. 6-8 weeks.

• In autumn 2023 it is possible to complete the course according to your own time table during 11/09/2023-15/12/2023. The final exam can be taken online on the following dates: 30th October, 13th November or 15th December 2022 at 9-12. 
• 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).

Study methods: 

• individual studies, learning diary, quizzes, online expert lecture (video)

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