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The FDAs DHF, DMR and DHR Design Dossier for

Documentation
Date: Wednesday, December

16th , 2015 || Time: 01:00 PM EDT | 10:00 AM PST

Duration: 90 Minutes || Course Level: Intermediate

'Live' Webinar by

John E. Lincoln

Register Now

Overview
The FDA's Design History Files, Device Master Records, Device History Record, and the
EU's MDD TF/DD -- Documentation to meet their different purposes and device
classifications. This webinar will examine the existing and proposed requirements for the
U.S. FDA's Design History File (DHF) per the CGMPs, 21 CFR 820.30 (j) -- including its
derivitive documents, the DMR (Device Master Record) and DHR (Device History / Lot
Record). It will consider the European Union's MDD Technical File /Design Dossier
requirements (similarities / differences), and evaluate the documents' differing purposes /
goals, as well as the two (FDAs and EUs) different device classification schemes.
Why should you attend?
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 Device (21 CFR 820) and Combination Products (21
CFR 4) 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 FiIe
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 webinar
This webinar will examine the existing and proposed requirements for the U.S. FDA's
DHF per the CGMPs, 21 CFR 820.30 (j) -- including its derivative documents, the DMR
and DHR. It will consider the European Union's MDD TF/DD requirements, and evaluate
the documents' differing purposes / goals, as well as the two different device
classification schemes. Required and desirable contents will be discussed.

Also considered: Areas requiring frequent re-evaluation / update; Similarities and


differences; Future trends. It will address typical DHF Table of Contents addressing the 9
must-have requirements of the cGMP guidelines; as well as the resulting DMR and DHR.
Then it will consider: Technical File or Design Dossier -- Table of Contents; The 13 key
requirements; The importance and usefulness of the "Essential Requirements";
Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel
approaches to development. Finally, the differing approaches to file audits by the FDA
and the Notified Body will be discussed.
Learning objective

What is the DHF, DMR, and DHR.


Meeting the cGMP requirements.
The 9 key elements.
The Technical File / Design Dossier.
The 13 key elements.
Similarities / Differences in the two document systems.
Suggested SOP contents for both documentation systems.
Understand what is required to compile either / both..

Who will benefit


Senior management in primarily in Devices and Combination Products
Professionals
QA/RA Professionals
R&D Professionals
Engineering Professionals
Operations Professionals
Manufacturing Professionals
Document Control Professionals
Speaker profile
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a
consulting company with over 33 years' experience in U.S. FDA
regulated industries, 19 of which are as an independent consultant. John
has worked with companies from start-up to Fortune 100, in the U.S.,
Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in
quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new
/ changed product 510(k)s, process / product / equipment including QMS and software
validations, ISO 14971 product risk management files / reports.. ViewMore