Applying Computer System Validation to Mobile Applications

Mobile applications can be validated as per FDA regulations using the same principles of computer system validation. For this to be compliant, development of an appropriate validation strategy to achieve the diligence required to prove that a system does what it is meant for is essential. This will help ensure that the application is maintained in a validated state throughout its entire life cycle, from conception through retirement.

If you are engaged in working on any mobile application that comes under the purview of the FDA; including but not limited to planning, executing, implementation or even if its providing support and maintenance services; this webinar will be exceedingly valuable. This webinar will help you understand and stay up to date on key best practices that deliver results while focusing on the most critical and cost-effective methods, techniques and tools available.

Joining the webinar will help you learn how to use the best practices across all systems in accordance with FDA requirements and create a standardized program by applying SDLC methodologies to mobile applications.

Areas Covered in the Session : 

• When validating how should mobile applications be handled 
• Best practices for maintaining a mobile application in a validated state
• Discuss the best practices necessary to ensure all systems, including mobile applications, are validated appropriately
• Learn how to develop the appropriate computer validation strategy when dealing with mobile applications 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, 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

Who Should Attend:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers

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.