Computer System Validation for Systems Supporting Clinical Trials 2015

Key Topics

• The best practices for maintaining a computer system in a validated state
• Gain an understanding of the Computer System Validation (CSV) and System Development Life Cycle (SDLC) Methodologies and how they are integrated
• Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risks, as clinical trial work can be extremely expensive
• Discuss the best practices necessary to ensure systems supporting clinical trial work are validated appropriately
• How to gain information about trends in validation, as industry progresses and new best practices emerge
• Effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state
• Assortment of computer system types that are used to manage clinical trials (data collection, analysis, reporting, statistics, trending, etc.)

Who should Attend

• Information technology analysts, clinical data managers and scientists, biostatisticians, compliance managers, lab managers, automation analysts, computer system validation specialists, GMP training specialists, business stakeholders and individuals who are responsible for validation planning