Edupliance announces a webinar titled, “Developing a Strategic Approach to FDA Compliance for Computer Systems” attendees will understand how to manage organizational change at the outset of a new system implementation project in order to avoid sabotage and other attempts to resist new ways of conducting business. The event will be held LIVE on Tuesday, Sep 25, from 01:00 PM to 02:30 PM, EST / 10:00 AM to 11:30 AM PST.
FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.
The 90-minutes webinar will be conducted by Experts Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, a medical device, tobacco, and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, computer system validation and large-scale IT system implementation projects. Carolyn participated in the Industry/FDA partnership that developed 21 CFR Part 11, the FDA’s guidance on electronic records and electronic signatures (ER/ES).
Webinar attendees will learn:
• Learn how to reduce the time and labor involved in a computer system validation effort by adequately planning your project
• Learn how to leverage GAMP 5 and the risk assessment approach to validate your systems in a streamlined manner
• Learn how to leverage past validation efforts to optimize results
• Learn how to ensure your team members are adequately trained to implement and maintain an FDA-regulated computer system in order to manage a successful outcome
• Learn how efficient and effective testing can ensure that all deficiencies are
captured before a system is put into production, allowing for a smooth go-live
• Learn how to keep on top of changes to the system over time to ensure it is
maintained in a validated state and does not require a complete revalidation due to neglect
To register for the webinar, visit
Edupliance is an online information provider which offers webinars (Live and On-Demand), DVD’s and downloadable resources that cover concurrent topics pertaining to various industries. With an expert panel of guest speakers, Edupliance brings state-of-the-art virtual technology solutions and industry-leading training sessions that are easy to learn, easily accessible and cater to people with varied interests. Edupliance is privately held and located in Hillsboro, Oregon.
For more information, visit