Live Webinar on : Design History File (DHF), Device Master Record (DMR),
Device History Record (DHR) and Technical File (TF) - Regulatory Documents
Explained
Thursday, August 09, 2012 duration : 01:00 to 02:00 PM EDT
Description
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CGO15
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:
Pricing
Live ( Single registration ) : $189.00
Group ( Max 10 Attendee): $249.00
On Demand (Recording available):$289
Get Training CD : $399
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
Who will benefit
- TF and OEM relationship
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
- Design/process changes and DHF, DMR, DHR,
and TF
About Speaker
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
oversees supplier management, CAPA, and document control.
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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