SIGHTSoHO
WEEKLY TRAINING MODULE 2
Licensing, authorisation and accreditation system
(including overview of inspection tools)
Schedule
04/12/2023 – 07/12/2023
Sub-topics
- Inspection Guidelines for EU Competent Authorities responsible for the inspection and authorisation of Blood and Tissue Establishments;Remote Virtual Inspection guidance document versus desk-based inspection;
- EuroGTP II risk assessment tool;
- GAPP Guideline for Preparation Process Authorisation (PPA);
- Mutual recognition tools (e.g., Common European SoHO Inspection Programme – CESIP, Joint inspections).
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.