Sinéad Masterson – tutor
Blood, Tissues and Cells, Organs
She worked for the Health Products Regulatory Authority (HPRA, Irish Competent Authority - CA) as Blood, Tissues and Organs Section Manager and Inspector of Blood, Tissue and Organ Establishments for over 10 years. She represented the HPRA at CA Meetings at the European Commission and was involved in several projects at a European level in the Blood, Tissues and Organs area.
Since 2016, she has been working as an Independent Consultant collaborating in a number of projects with the European Commission including most recently, the Evaluation Study and the Impact Assessment Study relating to the Revision of the Blood and Tissue 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
- Workshop 2 - Preparation process authorisation
- Workshop 3 - Biovigilance and hemovigilance
Miscellaneous
Login activity
- First access to site
- Sunday, 6 August 2023, 5:09 PM (1 year 43 days)
- Last access to site
- Tuesday, 2 July 2024, 12:10 PM (77 days 18 hours)