Increasingly U.
S.
companies are going global and 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...
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Increasingly U.
S.
companies are going global and 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 may soon borrow some features
required in the TF/DD.
Being aware of the similarities and differences can further
concurrent development and/or updates to both.
And what are DMRs and DHRs
relationship to DHFs, TF/DDs.
This webinar will examine the existing and proposed requirements for the FDA s DHF
and the MDD s TF/DD.
Their differing purposes / goals.
Required and desirable
contents.
Areas requiring frequent re-evaluation / update.
Similarities and
differences, and future convergences and trends.
Typical DHF Table of Contents.
Technical File or Design Dossier Tab
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