Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) - Webinar By GlobalCompliancePanel November 8, 2012

Overview: 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. Are you maintaining adequate DHF, DMR, DHR, and TF 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? Attend this Webinar to have these questions answered.

Why should you attend: 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 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?

Areas Covered in the Session:
FDA Quality Systems Regulation Requirements/Definitions
MDD Requirements/Definitions
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
Design/process changes and DHF, DMR, DHR, and TF

Who Will Benefit: This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation. This typically includes:
Quality Managers/Engineers
Production/Process Managers/Engineers
Manufacturing Managers/Engineers
QA and QC managers, inspectors, supervisors and personnel
Documentation Specialists
Supplier Quality Managers/Engineers
Regulatory 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. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Event Link - http://bit.ly/PVT0Oj