- Acquire a practical, well-structured and repeatable method of computerized systems GxP risk analysis.
- Be able to perform in complete autonomy a GxP risk analysis on any type of systems fulfilling the regulatory requirements.
- Meet the GxP requirements according to the most recent guidelines of the FDA including last Data Integrity guidances
- Be able to prepare the computerized systems validation using the new FDA “Risk analysis” approach.
- All the courses are based on ISPE and GAMP5 guidelines
- Case studies
- Working groups followed by a trainer
- Presentation and release of a synthesis paper
- Duration : 1 day
- Managers of : technical services, quality assurance and validation in the pharmaceutical sectors, medical devices, pharmaceutical chemistry and cosmetics.
Dates and costs
June 14th – Paris
Cost : 680 € excl. VAT, breaks and lunch included