L’evento avrà luogo il giorno 18 Febbraio 2020, dalle 8.30-18.00 in sala Arena in via Durando, 39 a Milano
WORKSHOP AGENDA
Speaker: Dott. Francesco Abbate
- Computer system validation general concepts
- Validation Effort and Methodology – risk based approach – Client vs Supplier
- Validation responsibility
2. Computer Validation Life Cycle
- Validation lifecycle general scheme – Planning documents
- Specification Documents
- Testing Documents
- Acceptance Documents
3. How to Maintain the Compliance Status
- Change Management, control and methodologies
- Periodic review, tools and methodologies
- Periodic Maintenance of Computer System inventory
- On-going procedures (Backup&Restore, Record Retention, Security, Use…)
4. ERES and Regulatory Requirements
- Overview of Electronic Records and Electronic Signatures (ERES)
- Different types of Electronic Record (input/output regulated/not regulated, permanent/not permanent)
- Applicable Regulatory Requirements and System Configuration
5. Remediation Activities
- Compliance Assessment methodology
- User Rights Review
- Examples of GAPs and Corrective Actions
- Analysis of GAPs Solutions
6. Example of CSV approach applied to a real computerized system (e.g. ICE Advice Pharma)
For more info and details e-mail AdvicePharma at gehad.shehata@advicepharma.com or call phone no. +390223992985