Good Manufacturing Practice in Pharmaceutical Industry (2 cr)
Code: C-01903-FA00CN70-3007
General information
- Enrollment
- 01.08.2024 - 03.01.2025
- Registration for the implementation has ended.
- Timing
- 06.01.2025 - 28.02.2025
- Implementation has ended.
- Number of ECTS credits allocated
- 2 cr
- Local portion
- 2 cr
- Mode of delivery
- Blended learning
- Institution
- Åbo Akademi, Åbo
- Teaching languages
- English
- Seats
- 0 - 15
- Course
- C-01903-FA00CN70
Objective
Learning objectives - after completing the course the students 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 Transferable skills - during the course, the following transferable skills will also be practiced: - Information-seeking skills - Problem-solving skills
Content
- Basics of pharmaceutical quality requirements - Good Manufacturing Practice guidelines (EU)
Location and time
Period III Online course
Materials
Eudralex Volume 4 Lundén Anna, Handbok i GMP (The GMP handbook), Key2Compliance AB Other material given on the course’s Moodle page.
Teaching methods
Online course: independent studies (learning diary, quizzes, online/video lecture)
Employer connections
Guest lecture, assignments and examination tasks where theory is applied on practical examples.
Student workload
Individual studies 50 h Exam 3 h Total: 53 h
Evaluation methods and criteria
Final exam (online)
Qualifications
No prerequisites.