Thursday 11th April, 2013
10:00am to 11:30am
Overview: The FDA QSR and the Medical Device Directive specify certain records that should be included in your organization's quality system - Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and Technical File (TF).
Are yours adequate? Do you know what information needs to reside and where it needs to reside? Many citations by FDA and notified bodies include findings with respect to insufficient information in the Design History File, not following the procedures to make the device as established in the DMR, and incomplete or inaccurate production data of incoming, in-process and finished products. 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.
Areas Covered In the Session:
FDA and MDD definitions/requirements
Design History File (DHF): Definition, Typical contents, DHF and outsourced design/production, DHF and OEM relationships
Device Master Record (DMR): Definition, Typical contents, DMR and outsourced design/production, DMR and OEM relationships, Controlling and maintaining DMR
Device History Record (DHR): Definition, Contents, Using DHR data for tracking and trending, DHR and outsourced design/production, DHR and OEM relationships
Technical File (TF): Definition, Contents , TF and outsourced design/production, TF and OEM relationship
Who will benefit:
QA and QC managers, inspectors, supervisors and personnel
Supplier Quality Managers/Engineers
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation.
Livermore Common, Fremont, CA, 94539
Event Link - http://bit.ly/137mtiZ
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11th April 2013