Course takes place from 17th to 18th of June 2025 at the Faculty of Pharmaceutical Sciences.
COURSE OVERVIEW
Interested in expanding your knowledge of Good Automated Manufacturing Practice (GAMP), Computerized System Validation, Regulations, and more? Experts from QbD Group will be instructing a 2-day training that will do exactly that. Check the information on the course below to decide if it suits your needs!
Production systems for the pharmaceutical and food industries have to comply with ever-stricter legislation. This training not only offers you theoretical knowledge of the basic aspects of GAMP – with a focus on the detailed life cycle – but also offers multiple practical exercises.
Additionally, a test will be provided so that you can check if you can apply your gained knowledge.The course begins with an introduction to GAMP principles and gradually builds to more complex examples and exercises.
Target Audience
The target audience are professionals or students in chemical, pharmaceutical & healthcare sciences and engineering.
- No prior knowledge needed
- Practical learning approach
- Ideal for more in-depth practitioners, who want to get more examples and use cases included as part of the training
Course has a 2-day programme:
Day 1
The following will be addressed:
Introduction to GAMP
Detailed Lifecycle
Regulations (21 Cfr part 11; Annex 11)
Extended Exercises on Validation, Specifications, Risk Assessment
Day 2
The following will be addressed:
Detailed Lifecycle and Verification Reporting
Operational Phase
Extended Exercises on Test Execution and Report, Validation, Requirements Matrix
COURSE PROGRAM
An overview of the course programme can be found in the following document.
Registrations are open for this course, please follow the ‘REGISTER HERE’ link above. If you have any questions please email Mark Gontsarik (mark.gontsarik@ugent.be).