WEEKLY TRAINING MODULE 2

Licensing, authorisation and accreditation system
(including overview of inspection tools)

 

 

Schedule

03/02/2025 – 07/02/2025



Sub-topics

  • Inspection Guidelines for EU Competent Authorities responsible for the inspection and authorisation of Blood and Tissue Establishments;
  • EuroGTP II risk assessment tool;
  • GAPP Joint Action and Guideline for Preparation Process Authorisation (PPA).



Learning objectives

  • To improve knowledge of the new inspection tools in order to harmonize the inspection methodology;
  • To understand the common approach for authorising new product/process and activities.



Required and Additional reading

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