Data integrity and computerized systems validation training course

21 June 2019


Denys Ostrovnoy



Course Objectives
  • To understand the mechanisms of contamination transfer from source to product and the protective measures in place to prevent product contamination
  • To have the opportunity to work with risk management techniques
  • To understand the key control measures and they impact the sterility assurance of the product
  • To introduce new thinking for qualification & validation based on risk assessment
  • To follow the EU GMP and cGMP regulations and guidelines for aseptic processing and to engage in discussions regarding industry changes and best practices


Target group
Anyone who wants to know more about GMP, such as quality control, quality assurance, and operations staff who perform GMP activities.




Data integrity: regulatory requirements


  • Data Management Policy
  • Data integrity risk analysis
  • Access control to computer systems and data protection
  • Review of the audit trail
  • Back up and data archive

14:00 – 15:30

  • Principles of computerized systems validation
  • Development of specifications (URS, FS, DS)
  • Quality assurance in computerized systems
  • Classification of software and its validation

15:40 – 17:00

  • Classification of hardware and its validation
  • IT transformation in the pharmaceutical industry
  • Quality assurance when using cloud systems (Quality in the Cloud)
  • Preparation for inspection



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