Training Course
Syllabus:
System Development Life Cycle (SDLC) Methodology and FDA-Regulated Systems Webinar
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. The areas covered in this webinar are:
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.
Why Should you Attend:
This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques and tools available.
Objectives of the Presentation:
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.
Who Should Attend
Information technology analysts, QC/QA managers and analysts, clinical data managers and scientists, analytical chemists, compliance managers, lab managers, automation analysts, computer system validation specialists, GMP training specialists, business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit. This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance. | 
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