ComplianceOnline

What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Records Explained

Instructor: Vinny Sastri
Product ID: 701057
Training Level: Intermediate
  • Duration: 85 Min

recorded version

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Read Frequently Asked Questions

This Webinar will describe, explain and clarify the differences between DHF, DMR and DHR . It will also detail the requirements and the expected contents of each record.

Why Should You Attend:
The FDA Quality Systems Regulations for Medical Devices specifies certain documents or records that should be included in an organization's quality systems - Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR).

Are you maintaining adequate DHF, DMR and DHR 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? What happens when design, development or production is outsourced?

Attend this Webinar to have these questions answered

Many citations by the FDA include findings with respect to (i) insufficient or lack of information in the Design History File, (ii) incomplete or absence of any documentation of design verification and design validation, (iii) discrepancies between the final design outputs and the Device Master Record, (iv) not following the procedures to make the device as established in the DMR, and (v) 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? 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, and provide examples for each one of them.

Areas Covered in the Seminar:

  • FDA Quality Systems Regulations, documents and records.
  • The Product Development Life Cycle.
  • Design History File (DHF).
    • Definition.
    • Types of documents and records.
    • Examples.
    • DHF and design firms
    • DHF and outsourced designs
    • Ownership and control of DHF
  • Device Master Record (DMR).
    • Definition
    • Description and typical content of a DMR
    • DMR and outsourced design
    • DMR and outsourced production
    • Ownership and controls of DMR
    • Controlling and maintaining DMR
  • Device History Record (DHR)
    • Definition
    • Contents
    • Using the data and information in a DHR for monitoring, tracking and trending
    • DHR and outsourced production
    • Ownership and control of DHR
  • Design changes and DHF, DMR and DHR
  • Process changes and DHF, DMR and DHR
  • Examples of a DHF, DMR and DHR
  • Conclusion and best practices

Who Will Benefit:

This Webinar is designed for people involved in across all functions in the product development and production life cycle and for those who develop and write protocols and reports, and record and analyze data. This typically includes:
  • Design and development directors, managers, engineers and technical personnel
  • Quality Directors, Managers and Engineers
  • Production and Process Directors, Managers and Engineers
  • Manufacturing Managers and Engineers
  • QA and QC managers, inspectors, supervisors and personnel
  • Documentation Specialists
  • Supplier Quality managers and Engineers
  • Regulatory directors and managers
  • Business managers

Instructor Profile:
Dr. Vinny Sastri, Ph.D., is the President of WINOVIA® LLC and has over 25 years experience in new product development and quality management with a strong track record in the healthcare, medical device, electronics, plastics and the automotive industries. He is a certified Six Sigma black belt. WINOVIA assists companies increase their growth and profitability via customized solutions, strategies, training and implementation of effective, self-sustaining new product development and quality management processes. Areas of expertise include quality systems, product design and development, design controls, manufacturing and process validation, FDA and ISO quality systems for medical devices and pharmaceuticals, risk management, CAPA and materials.

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