The course is aimed at those who work with computerized systems and need an overview of Good Automated Manufacturing Practice (GAMP).
Description
Computerised systems are an essential part of the pharmaceutical industry, from research and development to clinical trials, manufacturing and distribution. Computerised systems used in the GxP environment must be reliable and fit for purpose.
Good Automated Manufacturing Practise (GAMP) is a system for quality assurance of production equipment using validation according to a life cycle model and specifically designed by experts in the pharmaceutical industry to support the HUR and the interpretation of regulatory frameworks and to improve compliance and quality, efficiency and cost reductions.
This course gives you an understanding of regulatory requirements and how computerized systems should be quality assured in an effective way. After the training, you should have gained an overview of the content of GAMP 5 with a focus from a perspective for you as a specifier, client, supplier and manager of system solutions, for GxP and MDR regulated activities.
Instructor-led course
Our instructor-led courses are carried out by our most sought-after consultants as educators. Classroom days are complemented by online training, so you can still meet others with similar challenges even when you are unable to travel or be away from work.
If instructor-led course dates are missing for the course you want to attend or if you want to customize a course for your specific needs, you can contact us and together we can find the best solution for you.
Most of the instructor-led courses are organized with our partners
Läkemedelsakademin (The Swedish Academy of Pharmaceutical Sciences), Swedish Medtech & Swedish Labtech.
| GAMP 5 Quality assurance of computerized systems |
1 day |
Dates for planned courses can be found in the calendar or on the right side of this page.
Interactive e-learning
Essentials of
Essentials is for those who want to get a brief overview of a topic without in-depth training and tests. Our Essentials trainings are on average about 15 minutes long and do not include tests/certificates.
Principles of
Principles is for those who want a basic course in a subject. Provides a good foundation for learning more and includes the "Essentials of".
Advances of
Advances of is for those who want to gain an in-depth understanding of a topic. Here we recommend that you already have basic knowledge in the area or have completed our "Principles of" training in the area.
| GAMP 5 Ed. 1 | English |
| News in GAMP 5 Ed.2 | Swedish |
Also included in affordable Learning Packages on edu.plantvision.se.
Coming soon
.
| Essentials of GAMP 5 Ed.2 | English | Coming in spring 2023 |
| Principles of GAMP 5 Ed.2 | English | Coming in spring 2023 |
During planning
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| Advances of GAMP - Life Cycle Approach & phases | English |
| Advances of GAMP - Life Science Supplier | English |
