Computerized Systems Validation & Data Integrity In Pharma & Biotech

https://fleming.events/computerized-systems-validation-in-pharma-biotech/

This course is a compilation of topics representing recent challenges related to CSV, and how CSV relates to data integrity assurance.

Key topics:

• CSV considerations around data integrity
• Auditing GXP computer systems
• Inspection trends around CSV and data integrity
• Requirements for e-signatures/biometric signature
• Shifting to a data perspective
• Data requirements for validation
• Data migration and interfaces
• Verification & testing methods
• Iterative prototyping & agile methods
• Physical & logical security
• System overview document
• IT incident & change management in a GXP context

Training audience:

This Training Course is of particular interest to Pharmaceutical & Biotech industry:

• CSV consultants, experts, specialists
• Data integrity consultants, experts, specialists
• IT Quality
• IT Quality Compliance
• Quality Assurance
• Quality Systems
• Digital Quality
• Master Data Management
• Data Governance
• Validation