What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Records Explained

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Mar 04, 2010 End Date/Time: Apr 22, 2010
Early Registration Date: Apr 22, 2010
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Why Should You Attend:

The FDA Quality Systems Regulations for Medical Devices specifies certain documents or records that should be included in an organization's quality systems - Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR).

Are you maintaining adequate DHF, DMR and DHR records? Do you know what data and information need to reside and where does it reside? Are your records easily accessible? Are you confused by these terms? What happens when design, development or production is outsourced?

Attend this Webinar to have these questions answered

Many citations by the FDA include findings with respect to (i) insufficient or lack of information in the Design History File, (ii) incomplete or absence of any documentation of design verification and design validation, (iii) discrepancies between the final design outputs and the Device Master Record, (iv) not following the procedures to make the device as established in the DMR, and (v) incomplete or inaccurate production data of incoming, in-process and finished products. Is your company able to access all relevant documents detailing the design of your device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR? Do you know what information should reside in a DHF, a DMR and a DHR?

This Webinar will define, explain and clarify the different records, and provide examples for each one of them.


Online Event
2600 E. Bayshore Road
Palo Alto
United States