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.
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.
