Admission requirements
Only for students of the specialisation Industrial Pharmacy. Research Project 1 must be completed with at least an average of 7.5 for the components Practical work, Report and Oral presentation.
Description
This course gives an overview of the most important aspects of quality control/assurance in pharmaceutical manufacturing. It deals with the essential elements of the quality system and the supporting activities such as validation, qualification and change control. The course is adjusted to the most recent developments in the field of GMP concerning the changes in the European guidelines.
This course aims to:
Raise the awareness of the importance of Good Manufacturing Practice (GMP) in ensuring the quality and safety of medicinal products.
Provide an overview of the GMP terms, principles and laws.
Implement GMP in practice, including quality culture.
Learning to effectively engage with the specific position of the middle section in a pharmaceutical organisation.
Course objectives
At the end of this course the student is able to:
Describe and explain the GMP principles in the pharmaceutical production process.
Have insight in the 'gaps' within the organisation concerning GMP.
Identify GMP compliance and mistakes in the production process of a medicinal product.
Timetable
This course is offered by PCS from September 17-19, 2024 in Van der Valk in Breukelen.
Mode of instruction
Lectures and tutorials (case discussion).
Assessment method
This course will be concluded by a pass/no pass based on participation in all components of the course. Students must provide a certificate for the result to be registered in uSis.
Reading list
Will be announced during the course.
Registration
Enrollment via MyStudymap is not necessary for this course. Students need to enroll via the website of PCS (contact the coordinator of the specialisation for questions).
Contact
Coordinator of the specialisation Industrial Pharmacy: Drs. Judith Mathijssen, studyadvisorBPS@lacdr.leidenuniv.nl.
Remarks
This course is only available to students of the Industrial Pharmacy specialisation.
This information is without prejudice. Alterations can be made for next year.
Software
Starting from the 2024/2025 academic year, the Faculty of Science will use the software distribution platform Academic Software. Through this platform, you can access the software needed for specific courses in your studies. For some software, your laptop must meet certain system requirements, which will be specified with the software. It is important to install the software before the start of the course. More information about the laptop requirements can be found on the student website.