Manufacture of sterile pharmaceutical products training course

17 – 18 August 2015

Kiev

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.

GMP requirements.
Decision tree for sterilization choices for aqueous products.
Primary packaging washing and sterilization.
Qualification of steam sterilizers, dry heat oven and tunnel.
Sterilization processes validation
Drug formulation.
Sterile filtration validation.

Short presentation

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