The course is aimed at QAs for quality assurance of computerized systems (QA IT) or QAs who need in-depth knowledge of quality assurance of computerized systems. Also suitable for those who work as a quality manager and have overall responsibility for the company's quality management system.
Description
In the pharmaceutical industry, QA plays an important role in assuring the quality of the company's computerised systems for GxP-regulated operations.
This course provides in-depth understanding of the life cycle of a computerized system with a focus on interpretation of regulations and guidelines such as 21 CFR Part 11, EudraLex Volume 4 Annex 11 and Annex 15 and GAMP5.
After the training, you should have increased knowledge and understanding of regulatory requirements for computerized systems and how to practically apply regulations and guidelines for computerized systems.
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.
| QA IT Quality assurance of computerized systems |
4 days |
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.
During planning
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| Essentials of QA IT | ||
| Principles of QA IT |
