System Development Life Cycle (SDLC) Methodology and FDA-Regulated Systems

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.

Areas Covered in the Session : 

• 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.

Who Should Attend:

• Information Technology Departments
• Quality Assurance
• Quality Control
• Clinical Data Professionals
• Analytical Chemists
• Compliance
• Lab Managers
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Teams responsible for Computer System Validation Planning, Execution, Reporting, Compliance, Maintenance and Audit.

Course Director: CAROLYN TROIANO

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.