2-day In-person Seminar on “THE DHF, Technical File and Design Dossier - Similarities, Differences and The Future” at Las Vegas

THE DHF, Technical File and Design Dossier - Similarities, Differences and The Future

12 13 September 2013

One of our most popular subjects, 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 U.S. FDA's CGMPs mandate Design Control and the Design History File (DHF) at 21 CFR 820.30. In order to sell globally, the EU's CE-marking documentation is a requirement -- the Technical FiIe or Design Dossier, as described in their Medical Device Directive. What are the requirements for each file. 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 required content, as well as the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both.

1 speaker

  • John E. Lincoln Principal of J. E. Lincoln and Associates LLC, a consulting company

2 sessions

Day 1 Thursday 12th September 2013

Day 2 Friday 13th September 2013

Hilton Grand Vacations Suites at the Flamingo

United States United States / Las Vegas

3575 Las Vegas Boulevard South, Las Vegas, Nevada, 89109, 94539

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2 known attendees

  • GlobalCompliancePanel
  • John E. Lincoln

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