Device Master Record & Device History Record: A Regulatory Overview

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:

After completion of this webinar the attendee will have a thorough understanding of the what these two important parts of a GMP compliant quality management system are, and how they are established, implemented and controlled.

Two key elements of the Quality System Regulation requirements for the FDA cGMP are the Device Master Record and the Device History Record. These requirements are outlined in paragraphs 820.181 and 820.184 respectively. This webinar will outline the requirements for each of these two elements in significant detail to allow a device manufacturer to understand the requirements of these very important QSR elements for the medical device industry. As we move from the design process into the manufacturing process the Device Master Record is created.  As we move through the manufacturing process through the packaging and distribution process the Device History Record is created. Discussion will be made as to which documents need to be established and maintained in the Device Master Record and how the output of the Design Control process (the Design History File) contributes to both the DMR and the DHR. If you take the definition of Device Master Record as being the "Recipe" for the device, then the Device History Record is the "Evidence" that the recipe was followed. To have a standard operating procedure which defines the Device Master Record for a given device and to follow that up with an SOP which defines the specific contents of the Device History Record is imperative to maintaining a GMP compliant system. This webinar will provide practical examples of the both DMR and DHF elements and how they should be linked. Also a review of what should and should not be included in these records will be reviewed.

Areas Covered in the Session:

  • FDA QSR Requirements for DMR & DHR Including:
    • Section 820.181: Device Master Record
    • Section 820.184: Device History Record
  • How the Design History Record plays a role in the DMR/DHR Content
  • What Makes Up the DMR
  • What should be in the DHR
  • The Role of Operational Documentation in DMR/DHR
  • How Changes to the DMR Affect the DHR

Who Will Benefit:

  • Design Engineers
  • Quality Assurance and Quality Control Personnel
  • Program Managers
  • Manufacturing Engineers
  • Regulatory Personnel
  • Engineering Managers
Albert Cefalo, Regulatory Affairs Specialist, Analogic Corporation. Chuck has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University. For the last 21 years he has been employed by Analogic Corporation. During his career at Analogic he has involved in all activities related to Quality Assurance and Regulatory Affairs such as Creation and maintenance of SOPs, FDA, Health Canada and CCC submissions as well as served as Director of quality for several of Analogic's Business Units. Chuck also conducts in-house training on a variety of subjects. Chuck is the Regulatory Affairs representative on all of the Analogic Project Teams and provides an oversight of the Risk Management process.


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