FDAnews Announces — Understanding and Implementing the DMR, DHR and QSR Webinar, April 26, 2016

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The FDA expects manufacturers to maintain documents that describe the design and production of the device — Design History File (DHF), the Device Master Record (DMR), the Device History Record (DHR) and the Quality System Record (QSR). But knowing what exactly the FDA is looking for in these documents and how they relate to each other can be very confusing.

Understanding and Implementing the DMR, DHR and QSR
April 26, 2016 — 1:30 p.m. – 3:00 p.m. ET

Confused about what needs to be in the Device Master Record (DMR) and Device History Record (DHR)? What about their relationship to the Design History File (DHF) and Quality System Record (QSR)?

On April 26th industry expert Dan O’Leary of Ombu Enterprises, LLC, will explain the differences between each record, how they relate to each other, and show how to make sure they work together.

In ninety minutes, attendees will learn:

  •     The required elements in the Device Master Record (DMR)
  •     The source of the Device Master Record
  •     The required elements in the Device History Record (DHR)
  •     The linkage between the DMR and the DHR
  •     The requirements to release a device for distribution
  •     The relationship between the Device History File (DHF), DMR and DHR
  •     The role of the Quality System Record (QSR)
  •     The effect of UDI on these records
  •     The changes in ISO 13485:2016 related to these records

Meet the Presenter:
Dan O’Leary, President, Ombu Enterprises LLC
Dan O’Leary has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Dan is now President of Ombu Enterprises, LLC a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a Masters Degree in Mathematics; is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Who Will Benefit:

  •     Quality Managers
  •     Quality Engineers
  •     Quality Auditors
  •     Regulatory Managers
  •     Design & Development Managers
  •     Design Engineers
  •     Production Managers
  •     Production Supervisors
  •     Manufacturing engineers
  •     Individuals designated to release product for distribution
  •     Individuals designated to inspect, manage, and use labels

Webinar Details:
Understanding and Implementing the DMR, DHR and QSR
April 26, 2016 — 1:30 p.m. – 3:00 p.m. ET

$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/understandingimplementingDMRDHRQSR
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
+1 (703) 538-7665
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