Design History File (DHF) Device Master Record (DMR) Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained
Date & Time: Thursday, August 25, 2011
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Instructor: Jeff Kasoff
Price : $245.00
(for one participant)
Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc
This webinar will provide valuable assistance to all device manufacturers, those who market solely within the US, or those who wish to market in the EU as well.
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he reviews and approves supplier qualification, selection, assessment, and CAPA. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996. ...more
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, inprocess and finished products.
Why you should attend: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). 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.
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Areas Covered in the Session:
Your Necessity is our Priority
FDA Quality Systems Regulation Requirements/Definitions
MDD Requirements/Definitions Design History File (DHF) ¡ Definition ¡ Typical contents Device Master Record (DMR) ¡ Definition ¡ Typical contents ¡ Controlling and maintaining DMR Device History Record (DHR) ¡ Definition ¡ Contents ¡ Using DHR data for tracking and trending Technical File (TF) ¡ Definition ¡ Contents
Design/process changes and DHF, DMR, DHR, and TF
Click here to register for this webinar Who Will Benefit: This webinar will provide valuable assistance to all device manufacturers, those who market solely within the US, or those who wish to market in the EU as well. The employees who will benefit include: l l l l l l
Quality Managers/Engineers Production/Process Managers/Engineers Manufacturing Managers/Engineers QA and QC managers, inspectors, supervisors and personnel Documentation Specialists Supplier Quality Managers/Engineers
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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Published on Jul 7, 2011
This webinar will provide valuable assistance to all device manufacturers, those who market solely within the US, or those who wish to marke...