Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained

Training Options

  •   Duration: 60 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $295.00
  • Refund Policy

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
  • 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 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, CQM, is the Director of Quality at Medivators, a leading manufacturer of consumables and instrumentation in the endoscopy field. Among his responsibilities is oversight of the document control system. In his 20+ years of Quality and Regulatory management, Jeff has implemented and overseen document control systems at all sizes of company, from startup to $100 million in revenue. Over that time, he has also been primary liaison with FDA inspectors and notified body auditors. Jeff received his regulatory affairs certification in 1996, and his certified quality management certification in 2013.


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