Computerized Systems Validation & Data Integrity In Pharma & Biotech

Topics

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

Who should Attend

Attendees with job titles such as:

• CSV consultants, experts, specialists
• This Training Course is of particular interest to Pharmaceutical & Biotech industry:
• IT Quality
• Data integrity consultants, experts, specialists
• Quality Assurance
• IT Quality Compliance
• Digital Quality
• Quality Systems
• Data Governance
• Master Data Management
• Validation