Overview: This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation.
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
Design History File (DHF)
DHF and outsourced design/production
DHF and OEM relationships
Device Master Record (DMR)
DMR and outsourced design/production
DMR and OEM relationships
Controlling and maintaining DMR
Device History Record (DHR)
Using DHR data for tracking and trending
DHR and outsourced design/production
DHR and OEM relationships
Technical File (TF)
TF and outsourced design/production
TF and OEM relationship
Design/process changes and DHF, DMR, DHR, and TF
Who Will Benefit: This includes:
QA and QC managers, inspectors, supervisors and personnel