Admission requirements
Research Project 1 must be completed with at least an average of 7.5 for the components Practical work, Report and Oral presentation. Only available to students of the Industrial Pharmacy specialisation. The course Good Manufacturing Practice (GMP) for Middle Management must be completed.
Description
This training program is designed to equip professionals in the pharmaceutical industry and hospital pharmacies with the knowledge and skills necessary to effectively manage, assess and improve the quality of pharmaceutical products in sterile manufacturing environments. It focuses on the assessment of sterility assurance challenges, understanding their profound impact on product quality, patient safety and regulatory compliance and defend their decisions to the organisation and authorities.
This course provides a comprehensive understanding of sterility assurance challenges in pharmaceutical sterile manufacturing. Participants will gain practical skills, regulatory knowledge, and ethical perspectives necessary to ensure product quality, patient safety, and compliance with industry standards (GMP/ATMP/ICH). It prepares professionals to excel in their roles and make meaningful contributions to the pharmaceutical industry and hospital pharmacies.
Course objectives
This course aims:
To enhance knowledge of regulatory requirements and best practices for maintaining sterile product quality to be able to comprehend the regulatory landscape and apply that knowledge to ensure product quality and compliance with standards.
To create a deep understanding of concepts and sterility assurance principles in pharmaceutical sterile manufacturing techniques, cleanroom design and environmental monitoring to understand the risks, manage and mitigate sterility assurance.
To be able to apply tools and strategies for the development of a Contamination Control Strategy (CCS) .
A basic understanding of general pharmaceutical sterile manufacturing techniques and cleanroom design to understand the risks, manage and mitigate sterility assurance.
To be able to collect and assess the right information from the relevant people (Subject Matter Experts (SMEs)) to be able to make a decision on the relevant information.
To apply quality improvement strategies in a sterile manufacturing context and evaluate their impact on processes and outcomes.
To be able critically assess information, to make a decision regarding sterility assurance challenges, product impact and justify these decisions.
The ability to communicate and justify decisions effectively.
Timetable
This course takes place from 5-7 November 2024 in Van Der Valk Breukelen.
Mode of instruction
Lectures, self-tuition, discussion.
Assessment method
This course will be concluded by a written exam and an assignment. Each counting for 50% of the final grade.
For each individual exam, the grade is expressed by using a decimal integer between 1.0 and 10.0 that should be ≥ 5.5. The final grade is expressed using an integer between 1 and 10 and can be rounded off/up to a half integer, with the exception of the grade 5.5. Final grades between 5.50 and 5.99 will be rounded up to 6.0. The final grade should be 5.5 to successfully complete this course.
Reading list
Eudralex Vol. 4, Annex 1: Manufacture of Sterile Products.
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 for students of the Industrial Pharmacy specialisation.
This information is without prejudice. Alterations can be made for next year.