- Global Pharma News & Resources
09-Mar-2023 - 10-Mar-2023

Computerized Systems Validation & Data Integrity 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