Qualification and validation in manufacturing sterile products training course

20 – 21 October 2016


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.


Requirements for sterile pharmaceuticals.
Decision tree for sterilization choices.
Qualification of primary packaging washing machine.
Depyrogenation tunned qualification.
Moist heat sterilization.
Sterilizing filtration validation.
Aseptic process validation


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