ICH-Q3D training – March 2016

On March 8th, 2016, VAPI-UPIP co-organised a free seminar on the recently implemented ICH Q3D guideline on elemental impurities at the OMC (Open Manufacturing Campus) in Turnhout.

The following topics were covered in this seminar:

  • Presentation of the scope and content of the guideline, as well as the risk assessment approaches and control strategies to be followed (2 Bridge)
  • Discussion on analytical methodology and approaches to method verification/validation when testing elemental impurities (Toxikon)
  • A case study that presents possible approaches to risk assessments and control strategies (Expert team)
  • A panel discussion with team of experts and representative of FAGG/AFMPS