Simonetta Pupella – tutor
Blood
Hematologist. Post-doc in Transfusion medicine. Master on Quality and quality system. Qualified auditor of Healthcare Services. Deputy Director of the Italian National Blood Centre (CNS) in charge of Medical Affairs & Blood Inspection Systems. She is member of the Inspection expert subgroup (IES) and the Vigilance expert subgroup (VES) of the European Commission. She has been acting as technical team leader in several European projects and joint actions in the field of oversight activities. Full competence in all regulatory issues ruled by national and SoHO European legislation.
User details
- Timezone
- Europe/Berlin
Course details
- Course profiles
- Live opening event
- Module 01 - EU legal provisions
- Module 02 - Licensing, authorisation and accreditation system (including overview of inspection tools)
- Module 03 - Quality management system - Overview
- Module 04 - Quality Management System – Good practices
- Module 05 - Quality risk assessment
- Module 06 - BTC preparation process authorisation
- Module 07 - SoHO Vigilance and Biovigilance
- Module 08 - Serious adverse outcomes/rapid alerts and Harmonizing data collection
- Module 09 - Stock and critical supplies, Import/export, Single coding
- Module 10 - Inspection practice, inspection report and post inspection activities
- Module 11 - Risk for inspectorate
- Round 1 - Live closing event
- Workshop 1 - Inspection practice
Miscellaneous
Login activity
- First access to site
- Monday, 31 July 2023, 5:45 PM (290 days 16 hours)
- Last access to site
- Tuesday, 23 April 2024, 2:32 PM (23 days 19 hours)