DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions
May 12, 2015 - Fremont CA USCompliance4all
support@compliance4All.com
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One of our most popular webinars, 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. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/DD. 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. Areas Covered in the Session: The EU's MDD and the Technical File / Design Dossier Device Classification - U.S. FDA vs. EU MDD Design Control 'Over Time' vs. a Product's 'Snapshot in Time' - Differing Philosophies DHF "Typical" Contents and Deliverables The DMR and DHR / Lot / Batch Record TF / DD Required Contents Parallel Approaches to Documentation - Teams FDA and NB Audit Focus Compliance4All Adam Fleaming Phone: +1-800-447-9407 Event Link: http://bit.ly/1G7GQxD support@compliance4all.com www.compliance4all.com