Tue, 13 May
|Virtual Events
The DHF, Technical Documentation - Similarities, Differences and the Future
Faculty: JOHN E. LINCOLN | Date: May 13 - 14, 2025 | Time: 10 AM to 4 PM This seminar will examine the existing and proposed requirements for the U.S. FDA's DHF - including its derivative documents, the DMR, and DHR.
Time & Location
13 May 2025, 10:00 am GMT-5 – 14 May 2025, 4:00 pm GMT-5
Virtual Events
About the event
Description
Key regulatory documents are continuously updated with the latest U.S. FDA and European Union requirements. As U.S. companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical File or Design Dossier under the old MDD, and the Technical Documentation requirements of the new MDR. Currently, they serve different purposes and support different goals, but the TD File is moving in the direction of the DHF.
And the DHF is adapting to some of the features of the TD File. And how / where do the DMR and DHR fit? Being aware of the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both.
WHY YOU SHOULD ATTEND
This seminar will examine the existing and proposed…
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