Device Software Verification and Validation
An FDAnews On-Demand Webinar
Offered for One Day Only, Aug. 12, 2014 • At Your Convenience
The FDA is focusing on medical device software verification and validation. What can you do to prepare?
Mark your calendar for Tuesday, Aug. 12, for On-Demand access to John Lincoln’s immensely popular webinar on software verification and validation.
Here’s what our satisfied registrants had to say on what they liked about this webinar:
The software associated with medical devices is under closer scrutiny than ever before because of increasing prevalence in industry, greater chance for problems, and the comfort level of FDA investigators in asking for and auditing software applications.
Mark your calendar for Aug. 12, when veteran FDA consultant John Lincoln explains what the FDA expects of you now, and how to achieve it in a hurry.
In a 90-minute, in-depth chalk talk, Mr. Lincoln demonstrates a preferred FDA 11-element documentation model in various applications, including ERP, in-device, as-device, process/equipment control and cGMP data/Part 11 applications.
He addresses use of FDA guidances, GAMP 4/5, 21 CFR 11 and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Risk Management models and their real-world implementation.
You’ll come away with an actionable understanding of:
Software design and validation cuts across department lines. You’ll want to make sure senior executives participate from both the quality and manufacturing sides, including software development, programming, documentation, testing, QA/RA, R&D, engineering, production and operations. Fortunately, there’s just one low registration fee per participating facility, so go ahead — put out a companywide memo and book a big room right now.
Device Software Verification and Validation will give you a clear understanding of FDA expectations and how to meet them, with a specific focus on software that is as-product, in-product, process and/or in overall manufacturing and operations. Why risk FDA sanctions, let alone multimillion-dollar liability lawsuits?
Please note; this webinar has been previously recorded and no questions will be taken during the presentation. You may listen to the recording at your convenience on Aug. 12.