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. The course is also held in cooperation with Läkemedelsakademin (The Swedish Academy of Pharmaceutical Sciences)
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.
The training days then consist of a combination of lectures and practical exercises in the form of group work with subsequent discussions for different types of computerized systems. Participants have the opportunity to request CASE to discuss together on the last day of the course. 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.
Who should attend?
- QA IT
- QA, quality assurance
- Quality Manager
Quality Assurance (QA) for
- Implementation of a computerised system in GxP-regulated activities (investment projects, upgrade projects, IT projects, etc.).
- Qualification/validation of computerised systems in the pharmaceutical industry.
Content
Quality assurance of computerised systems and practical application of regulatory requirements for:
- Computerised systems in the manufacture of medical devices
- Computerized systems in laboratory with GMP requirements or similar
- Computerised systems in distribution following GDP (distribution of Pharma)
- The company's GMP-related IT system (e.g. document, deviation or change management system, etc.)
Practical application of regulatory requirements for computerised systems with a life cycle perspective and the role of QA in
- Procurement of computerised systems - Requirements & Vendor Assessment
- Qualification/Validation - Classification of systems and their complexity
- Management - Change Management & Periodic Review
- Risk management
- Settlement
Prerequisites
You need to have completed a basic training in Validation and GAMP and have previous theoretical and practical experience in QA work and qualification.
You will be expected to have carried out self-study for the occasion on current versions of:
- 21 CFR Part 11
- EudraLex Volume 4 Annex 11 & Annex 15
- GAMP 5
