DELTENRE Fabian (EFOR-CVO)

Compétences

Computer system validation :

• Pharmacovigilance systems
• R&D Robotics & image analysis systems
• Custom developed systems (GAMP 5)
• Laboratory equipment systems
• Clinical trials management systems
• SoftmaxPro systems
• Excel systems (with VBA)
• Statistical systems (R and SAS)

Data Integrity :

• Implementation of DI programs following authority guidance
• DI verification and implementation on CS
• DI training

Project Management :

• Definition of project planning
• Identification of project risks
• Budget and resources management

Diplôme(s) – Qualification – Certification

Master in Computer Sciences (Operational Research).
Master in Biological Sciences.

Expérience

Experience in pharmaceutical industry and biopharma (R&D, pharmacovigilance, clinical studies).
Expertise in Computer System Validation (CSV) and data integrity.

Formation

Data Integrity – Mise en conformité
Validation des systèmes et des équipements de laboratoire (VSEL)