Computerized systems engineering, quality, compliance

Computerized systems risk analysis (1 day)

Course objectives

  • 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.

Training methods

  • 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

Audience

  • 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