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23. 05. 2025
Online training course: Good Manufacturing Practice (GMP) according to the European Union (EU) guidelines
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| Good Manufacturing Practice is an important factor in ensuring that a medicinal product is of high quality, effective and safe. GMP principles must be followed at all stages of the manufacturing process and it is essential that manufacturers of medicinal products are aware of the importance of their application. |
AimIn the e-training, we will present the requirements of good manufacturing practice according to European guidelines (EU GMP) for human and veterinary medicinal products through practical examples, and at the end, we will consolidate understanding of the requirements with a knowledge test. Therefore, we also recommend this seminar to newly employed or beginner employees. |
Content
- Introduction to GMP
- Basic GMP requirements for medicinal products (quality system, personnel, premises and equipment, documentation, production, quality control, outsourced activities, complaints and recalls, internal audits)
- Computer systems (including 21 CFR Part 11 requirements)
- Validation and qualification of facilities, equipment, and processes
- Discussion of practical examples
- Summary of presented topics
- Written exam
Work method
- The e-training consists of lectures, experience sharing, and a written exam.
- It takes place live online.
- Two days before the event, you will receive a web link to the e-mail address you provided at the registration.
- To participate in the e-training, you will need a computer with a microphone and a camera and a reliable internet connection.
Target group
- Manufacturers of medicinal products.
- Contractors involved in the manufacture of medicinal products.
- Testing laboratories for the analysis of medicinal products.
- Manufacturers of input materials (active substances, excipients, packaging) for medicinal products.
- Quality management system auditors and consultants.
- Users of medicinal products.
 | You will receive a certificate of attendance upon completion of the e-seminar. |
| Don't miss the opportunity to gain a comprehensive insight into Good Manufacturing Practice (GMP) according to European Union (EU) GMP guidelines. |
Additional information: Bojan Varga, phone: +386 1 477 81 08, e-mail: bojan.varga@siq.si
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