Good practice in blood components and medicinal products referring to GPG and GMP - Edizione 1

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Da 27.02.2018 08:00 fino a 01.03.2018 18:00
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Rilevanza

Quality management and inspection of blood establishments are a key stone in achieving best practice and guaranteeing the safety of blood and blood components for transfusion of patients. The European Blood Inspection System (EuBIS), initiated under the Public Health Programme of the European Commission, Directorate General SANCO, has developed a manual and training guide containing standards and guidelines for quality management and the inspection of blood establishments. Based on the EuBIS manual and guide the EuBIS Academy has organised training seminars and courses in order to promote knowledge in the area of quality and safety of blood and blood components throughout Europe and worldwide.

Scopo e obiettivi

The seminar will build on previous EuBIS training courses with the scope to train on the impact of the new regulation of Good Practice Guidelines (Directive 2016/2014) amending Directive 2005/62/EC for blood and blood components in the European Union.

Obiettivi specifici

1. Analyzing and applying the new regulation of Good Practice Guidelines (Directive 2016/2014); 2. Conducting inspections on blood establishments according to GP and GMP guidelines.

Metodo didattico o di lavoro

The seminar comprises lectures and group work in a face-to-face fashion based on cases covering several aspects of GP and GMP such as: • GP guidelines • Inspection/audit • Validation • Change control • Corrective actions • Risk assessment


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