FERNANDEZ Anne-Marie (EFOR-CVO)
Compétences
Quality systems
- Quality review
- Preparation of validation master plan
- Revise and implement procedures (SOPs) in the quality system
- Change and incidents management
Validation/Qualification
- Quality review of validation/qualification deliverables
- Data risk analysis
Audits (Certified ISO 19011 and IRCA ISO 9001)
- Realise audits in several regulations : GLP, GMP (EU, US), GDP, ISO 9001:2015
- Gap analysis on Data Integrity, validation of systems and laboratory systems
Diplôme(s) – Qualification – Certification
- Research Associate – UCL
- PhD Thesis (Organic Chemistry), DEA
Expérience
25 years of experience in life sciences : Internal audit (technical and system), external audit (clients and regulatory), data integrity, validation master plan quality assurance (computerised system validation, quality reviews).