Fewzi Teskrat – tutor
Blood, Tissues and Cells, Organs
Medical doctor. He has 5-year experience in clinical trials on medicinal products and almost 20-year experience in SoHO inspections, including joint inspections with EU and third-Countries. He was the head of Unit of the inspection department of the French CA. He participated as trainer in many EU projects and as expert in some WHO projects. He was member of the CDPTO (EDQM). He supported several European and third-Country CA for the development and improvement of their inspection systems. He is the leader of a work-cluster on Inspection guidelines and Common EU format for the Inspection Report of EC Inspection Expert Subgroup. He is the co-founder of the EuBIS Academy.
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
- Thursday, 13 July 2023, 3:20 PM (1 year 14 days)
- Last access to site
- Tuesday, 27 February 2024, 3:51 PM (150 days 18 hours)