This webinar will discuss the System Development Life Cycle (SDLC) Methodology and the importance of following this approach when validating computer systems subject to FDA regulations. Upon completion of this session, attendees will have an understanding of how to apply the SDLC to computer system validation, and develop a sound strategy for meeting FDA compliance.
The attendees will understand the level of effort required for executing each phase of the SDLC, and the appropriate level of documentation that must be completed to support it. They will also gain an understanding of the training and skills required to apply the SDLC to systems when validating or maintaining them. The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program for applying the SDLC to systems in accordance with FDA requirements.
- System Development Life Cycle (SDLC) Methodology.
- How to develop the ability to apply the SDLC when validating computer systems in your organization.
- The best practices for maintaining a computer system in a validated state.
- The best practices necessary to ensure all systems are validated appropriately.
- How to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk.
- Understand how to 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.
- How to gain information about trends in validation, as industry progresses and new best practices emerge.
- Understand some of the key “pitfalls” to avoid when applying the SDLC methodology.
- Information Technology Departments
- Quality Assurance
- Quality Control
- Clinical Data Professionals
- Analytical Chemists
- Lab Managers
- Automation Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Teams responsible for Computer System Validation Planning, Execution, Reporting, Compliance, Maintenance and Audit.