This webinar will discuss how computer system validation can be applied to mobile applications subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.
Areas covered in the webinar include:
- How mobile applications should be handled when performing validation work.
- Best practices for maintaining a mobile application in a validated state.
- Best practices necessary to ensure all systems, including mobile applications, are validated appropriately.
- How to develop the appropriate computer validation strategy when dealing with mobile applications to ensure a good balance of cost vs. risk.
- How to effectively document the process of computer system validation, and maintain current information about the various systems in your organization, as they begin to include mobile applications.
- Learn how to gain information about trends in validation of mobile applications, as industry progresses and new best practices emerge.
- Understand some of the key "pitfalls" to avoid when applying the concepts of computer system validation to mobile applications.
Why You Should Attend:
You should attend this webinar if you are responsible for planning, executing or managing the implementation of any mobile application that is part of a system governed by FDA regulations, or if you are maintaining or supporting such a system. 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 concepts of computer system validation to mobile applications, 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 when validating or maintaining mobile applications.
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 mobile applications 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 (specifically mobile application) planning, execution, reporting, compliance, maintenance and audit. This webinar will also benefit consultants working in the life sciences industry who are involved in mobile application implementation, validation and compliance.