DMR & DHR - What Is Really Required

Why Should You Attend:

Have you ever been confused about what needs to be in your Device Master Record (DMR) and your Device History Record (DHR)? This webinar will help you understand the requirements and assemble a complaint DMR and use it to build your DHR.

The webinar will also help you understand some very important related documents. The Design History File (DHF) is part of the design project, and does not duplicate the DMR. The webinar will help you understand the difference. In addition, the Quality System Record (QSR) can be a valuable adjunct to the DMR. The speaker will advise you on when to put device information into the QSR.

The contents of the DHR are in 21 CFR §820.184, or so it seems. Unfortunately, there are additional DHR requirements spread throughout the regulation. For example, disposition of nonconforming material can impact the DHR as well as records (produced by designated individuals) of the primary labels. This webinar compiles these additional requirements and explains them.

Learning objectives:

• State the four major records required in FDA’s QSR.
• Describe the contents of the Design History File (DHF).
• Explain the source of the Device Master Record (DMR).
• Describe how the Device History Record (DHR) relates to the DMR.
• State the required content of the Quality system Record (QSR).
• Explain the difference between information if the DMR and the QSR.
• Understand the concept of a “designated individual” and the qualifications.

Areas Covered in the Seminar:

• The FDA’s QSR.
  • The source of the requirements
  • The preamble
  • The QSR Manual
  • OMB information collection
• Key Definitions
• Design History File (DHF).
  • Requirements
  • Content
• Quality System Record (QSR)
• Device Master Record (DMR)
• Contents
• Linkage to Design Controls
• Lessons for Implementation
• Device History Record (DHR)
  • Contents
  • Linkage to the DMR
  • Lessons for Implementation

Related Technical Documents:

• 21 CFR Part 820 Quality System Regulation
• 21 CFR Part 820 Preamble (61 FR 52601, et seq.)
• Medical Device Quality Systems Manual: A Small Entity Compliance Guide
• Information collection for QSR, OMB No. 0910-0073

Who Will Benefit:

This webinar is for people involved in project management, design, production, purchasing, installation, servicing, document control, and record keeping activities for medical device manufacturing.

People in the following roles can especially benefit from the knowledge in this webinar:

• Quality Managers
• Quality Professionals
• Regulatory Professionals
• Production Managers
• Risk Managers
• Project Managers
• Production Supervisors
• Manufacturing Engineers
• Production Engineers
• Design Engineers
• Process Owners
• Quality Engineers
• Quality Auditors
• Document Control Specialists
• Record Retention Specialists

Instructor Profile:

Daniel O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. 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.

Topic BackGround:

The FDA's QSR expects the manufacturer to maintain a series of documents that describe the design and production of the device. QSR allocated the information into four documents.

• The Design History File (DHF) gives a history of device design. One of the design outputs is the Device Master Record (DMR).
• The Device Master Record (DMR) contains all the information necessary manufacture, install, service, and maintain the device.
• The Device History Record (DHR) has the objective evidence to support the device production history.
• The Quality System Record (QSR) contains information that is not device specific.

The four sets of documents fit together in a structure that helps assure correct device manufacturing. The content of the documents and the allocation of information depends on your manufacturing system; you should tailor the approach to your company’s products and approaches.