Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) - Webinar

  • ID: 4428061
  • Webinar
  • 60 Minutes
  • NetZealous
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Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) Do you find yourself constantly struggling to create, manage, and maintain all of the information found in DHFs, DMRs, and DHRs - which is often redundant, repetitive, and chained together in a cumbersome way?

Do you find that your design and manufacturing resources are spending way too much time on documentation and not enough on engineering and design? This webinar presents a fresh new approach based upon solid principles and proven practices as well as an alternative that avoids many of the pitfalls of traditional ways of preparing these documents.

Areas Covered in the Session:

Brief introduction to Lean Documents and Lean Configuration.
Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents.
Design History Files (DHF) content, development, and management.
Device Master Records (DMR) content, development, and management
Device History Record (DHR) content, development, and management
Applying lean principles to creating, developing, and managing a DHF
Applying lean principles to creating, developing, and managing a DMR
Applying lean principles to creating, developing, and managing DHRs
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  • Jose Mora Jose Mora,


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  • Managers, Supervisors, Directors, and Vice-Presidents
  • R&D
  • Manufacturing Engineering
  • Design Assurance
  • Quality Assurance
  • Operations
  • Document Control
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