DHF, DMR, DHR and TF - Regulatory Documents Explained 2013
11 Apr 2013
Webinar
Description
Topics
Design History File (DHF): Definition, Typical contents, DHF and outsourced design/production, DHF and OEM relationships
FDA and MDD definitions/requirements
Device History Record (DHR): Definition, Contents, Using DHR data for tracking and trending, DHR and outsourced design/production, DHR and OEM relationships
Device Master Record (DMR): Definition, Typical contents, DMR and outsourced design/production, DMR and OEM relationships, Controlling and maintaining DMR
Technical File (TF): Definition, Contents , TF and outsourced design/production, TF and OEM relationship
Who should Attend
Production/Process Managers/Engineers
Quality Managers/Engineers
QA and QC managers, inspectors, supervisors and personnel
