GlobalSubmit recently held an educational webinar on the Understanding the New FDA Validation Criteria. The purpose of the webinar was to provide an overview of the US FDA’s draft version of the new “Specification for eCTD Validation Criteria,” which outlines many of the new error conditions that the FDA will be checking for in the next version of its validation software. During the webinar, facilitated by Daniel Clark, Sr. Manager,...
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.
The US FDA has posted a draft version of a new “Specification for eCTD Validation Criteria” which can be found here. This document outlines many of the new error conditions that the FDA will be checking for in the next version of the validation software. I will be highlighting some of the more important changes to the criteria.
The European region is going to put new validation criteria into effect in September 2011. The previous priority levels of A, B, and C have been removed, and have been replaced by Pass, Fail, and Best Practice.
Study Tagging Files XML is a very common area of confusion for most people new to eCTD and XML in general. I have spent a lot of time creating the XML for sequences by hand, and have examined sponsors’ XML to determine the location of the error. Because of these experiences, I thought it would be beneficial to discuss the basic structure of the index.xml, stf.xml, and the single most common question I receive related to the STF which is, “Why am I seeing errors 1952, 1953 and are these the same error?”