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Main Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained
Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained Call: 800-447-9407
Instructor : Jeff Kasoff
Product Id : 600642
Duration: 60 Minutes
Tuesday, February 14, 2012 10:00 AM PST | 01:00 PM EST 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.
Pack of THREE: Best Selling Webinars by GlobalCompliancePanel
b Live live online training only for one participant c d e f g Price: $245.00
c Corporate Live 2 to 5 participants from a single location (For multiple d e f g locations contact Customer Care) Price: $495.00
c Corporate Live 6 to 10 participants from a single location (For multiple d e f g locations contact Customer Care) Price: $995.00
c Recorded Access recorded version only for one participant; unlimited d e f g
viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar) Price: $295.00 Refund Policy
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?
Pack of THREE: Best Selling DHFDMR-DHR Webinars by GlobalCompliancePanel
Customer Testimonials of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,
I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but
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 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.
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Published on Jan 18, 2012
The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality sys...