Course description:

• This training session is recommended for personnel with previous experience in Quality Management System in GxP areas.
• Training structure includes presentations of following theoretical concepts, interactive sessions and customised case studies.

• • • GxP system
    • Regulatory Requirements
    • GxP Impact
    • V Model Phases. Deliverables
    • Computerised System lifecycle
    • Responsibles & Main Responsibilities in IT System validation
    • Risk analysis
    • Qualification vs Validation
    • Qualification. Deliverables
    • Testing. Deliverables
    • Traceability Matrix
    • Qualification & Validation Status/Reports
• Course Lecturer: Pharm. Elena Georgescu – Acquired expertise in 25 years of operational experience in pharmaceutical industry GxP compliance areas.