It's always challenging to optimize the approach to validating an FDA-regulated system and maintaining it in a state of compliance throughout its life cycle. The initial validation process can be streamlined by adequately planning all aspects of the effort. There are specific practices that can ensure the system is thoroughly and adequately designed, developed, implemented, tested and ready for production while avoiding the many potential pitfalls often encountered during the process. There are many examples of both the best practices and potential pitfalls that will be shared to ready you for your journey in FDA compliance.
In this webinar, you will learn how to do your due diligence in computer system validation by applying industry best practices and avoiding the potential pitfalls encountered by many. You will also learn how to manage these over the longer-term maintenance of a system, ensuring compliance with FDA throughout the system's entire life cycle.
Topics covered include:
Duration: 75 Minutes
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
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, providing very creative and interactive presentations. 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.