Ludivine RICHARD
CEO IPARDIS Consulting | SYSTEMES INFORMATISES | QUALITE | CONFORMITE GxP & VALIDATION | DATA INTEGRITY | CYBERSECURITY
SMALL STREAMS MAKE BIG RIVERS
Autonome - Organisée - Pédagogue
Esprit d'équipe
Orientation résultat - Proactivité
36 ans
Permis de conduire
Libourne (33) France
Situation professionnelle
Entrepreneure
Ouverte aux opportunités
Présentation
Experte en réglementation GxP des SI avec plus de 10 ans d'expérience, j'accompagne les professionnels du secteur des industries de santé dans la conformité, cybersécurité et la gouvernance qualité de leur SI.
Cursus de formation et prise de connaissance des procédures permettant de remplir les fonctions d'expert validation des infrastructures informatiques
Modules, options, contenu des cours
- Quality Risk Management for GxP Computerized Systems Standard
- Standard PUMA training
- GxP Awareness for Computerized Systems
- Personnal Data Protection
- ITS Quality Document Management
- Preparing and writing a Standard Operating Procedure (SOP) in an effective way
- ITS Quality Training Management
- Data Privacy
- Management of ITS Corrective and Preventive Actions
- Electronic Signatures in GxP Environment
- Computerized System Validation SOP
- Management of GxP Electronics Records and Electronic Signatures Directive
- Computerized Systems Third Party Audit Management SOP
- Business Continuity Plan for GxP Computerized Systems Guidance
- Quality Fundamentals
- Change Management process
- Good Documentation Practices Awarness training
- Infrastructure Qualification procedure
- Installation Qualification procedure
- ITS IS Anomaly Management procedure
- Qualification of Personnel and Training Management in ITS Infrastructure Services
- Quality and Security review process with accenture
- Release Management procedure
- How to approve a change
- How to execute a deployment
- Incident Management process
- Problem Management Process
- Data Integrity standard