Free Webinar: Understanding the New FDA Validation Criteria

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The US FDA recently posted a draft version of a new “Specification for eCTD Validation Criteria,” outlining many of the new error conditions that the FDA will be checking for in the next version of its validation software.  With the FDA getting tougher on technical issues, it is critical that your application is not only structured correctly, but also free of technical errors, especially high severity errors. Most importantly, it must be ready for review by the agency upon submission. Based on the current quality of the submissions the FDA receives, many can expect to receive a technical rejection. This can cost a sponsor anywhere from 4 days to 1 week of delayed approval time and tens of thousands of dollars (possibly much more depending on the expected product revenue), not to mention the man hours spent correcting the issue.

That’s why GlobalSubmit is offering a free educational webinar on Understanding the New FDA Validation Criteria on Thursday, October 20th at 11:00am EDT.

During this discussion, we will focus on some of the more important changes to the criteria, when the new validation criteria will go into effect, best practices for ensuring your application is free of technical errors, and more.

Top 3 Learning Objectives:

    • Understand why there are new validation criteria
    • Understand how the FDA uses these validation criteria
    • Learn how the new validation criteria affects you

About Jason Rock, CTO, GlobalSubmit

Mr. Rock is a technology visionary and leader within the eCTD community at large. He has over 10 years of experience working with global life sciences companies and regulatory agencies to promote the adoption of the eCTD through the development of advanced applications. In his role as CTO, Mr. Rock provides strong leadership for the strategic and technical direction of GlobalSubmit’s product architecture and development. He is a frequent guest speaker at numerous industry forums such as DIA, RAPS and others. Mr. Rock chairs the HL7 Regulated Product (RPS) initiative and works closely with the U.S. FDA for their deployment of GlobalSubmit applications as well as various technology programs involving regulatory submissions. 

Event Details

When: Thursday, October 20th at 11am EDT
Where: Web & Teleconference
Who: Presenter, Jason Rock, CTO, GlobalSubmit; Moderator, Dan Clark, Senior Manager Regulatory Operations & Innovation, NovoNordisk

For more information and event details: GlobalSubmit Events

Author: GS

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