Good Manufacturing Practices for Medicines and GMP inspections - general
This e-learning course introduces Good Manufacturing Practices for medicines. The course focuses on the standards set forth by the WHO as one of the most important promoters and enforcers of GMP. Course participants will learn about the GMP requirements and their procedural, organisational and infrastructural repercussions. They will also learn about and get prepared for the GMP inspection process.
At the end of the course, successful participants from local manufacturers and national regulatory authorities will be able to critically analyse and implement basic GMP requirements in their daily working routine in the manufacturing and regulatory environment. They will thus be better equipped for the production and regulation of quality assured essential medicines in line with national and international standards.
If you are interested in this course, do not hesitate to contact: email@example.com
After having successfully completed the course, participants will be able to:
What are the target participants?
The course is designed for all health personnel, business administrators and managers involved in the health sector, development cooperation, healthcare programmes and projects in developing countries. No prior knowledge is required, although practical involvement in the health sector is an advantage.
Teaching and learning strategy
This e-course requires the students to go through the course materials on the learning platform with the support of an online facilitator to encourage self-directed learning. Taking part in discussion forums, exchanging ideas with fellow participants and completing online quizzes will form a vital part of the learning experience.
Assessment and grading
Participants will be graded based on their online participation and completion of activities. A certificate of completion and an e-badge will be awarded to all those who complete a minimum of 75% of all online activities (lessons, quizzes, discussion forums). The percentage of completion will be measured automatically online as the participant goes through the course.
In addition, there are several short assignments to guide the learning process of the participants, offering feedback on the submissions and an opportunity to interact with the facilitator. Assignment responses should be submitted within the respective due dates (one week after opening) as to the schedule below.
Level of effort: 4 hours per week