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      Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained - Webinar By GlobalCompliancePanel in Wilmington

      • Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained - Webinar By GlobalCompliancePanel Photos
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      January 2, 2011

       

      1000 North West Street Suite
      Wilmington, Delaware 19801

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      EVENT DETAILS
      Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained - Webinar By GlobalCompliancePanel

      Event Name: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained - Webinar By GlobalCompliancePanel
      Event Date(s): Sunday, January 02, 2011 to Sunday, January 02, 2011
      Event Location: Online Training Webinar, Wilmington, Delaware, U.S.A.
      Cost: $245.00
      Description: 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.

      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 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
      Host Company: n/a
      Contact Information: Phone: 800-447-9407
      Fax: 302-288-6884
      Email: webinars@globalcompliancepanel.com
      More Information: http://www.globalcompliancepanel.com/control/w_product/~product_id=600350?channel=mailer&camp=webinar&AdGroup=devicespace.com

      Cost: 245.00

      Categories: Science | Technology

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.
      COMMENTS ABOUT Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained - Webinar By GlobalCompliancePanel