Online Webinar 2019 - 90 Minutes Live Webinar Applying Computer System Validation (CSV) to Mobile Applications

Description of the topic
We will discuss in detail 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.
Session Highlights
• Gain an understanding of how mobile applications should be handled when performing validation work
• Understand the 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
• Q&A
Why should you attend
You should attend this seminar 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.
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance. As technology has continued to evolve, including the usage of mobile applications, we encounter new challenges that must be met.
There is an enormous body of documentation and information available that can be overwhelming. 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.
Who will benefit
Professionals in the following industries may also benefit from the content:
• Pharmaceutical
• Medical Diagnostics
• Biotechnology
• Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
• Data “Owners”
• Data “Stewards”
• 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
• Computer System Validation Specialists
• Business Stakeholders/Subject Matter Experts
• Compliance training specialists
• Consultants working in the life sciences
Faculty
Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, 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 collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.