Design History File Device Master Record and DHR Utilizing the Principles of Lean Documents and Lean Configuration

Design History File Device Master Record and DHR Utilizing the Principles of Lean Documents and Lean Configuration

 

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About The Event

This webinar will explain how to create, develop and manage Design History Files (DHFs), Device Master Records (DMRs), and Design History Files (DHFs) using lean document and lean configuration methods.

Why Should You Attend:

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 will present 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 Webinar:

  • Brief introduction to Lean Documents and Lean Configuration
  • Quality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to DHF, DMR, and DHR
  • 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

Who Will Benefit:

This webinar will provide valuable assistance to Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

  • R&D
  • Manufacturing Engineering
  • Design Assurance
  • Quality Assurance
  • Operations
  • Document Control

 

For Registration: http://www.complianceonline.com/creation-of-dhfs-dmrs-and-dhrs-using-principles-of-lean-documents-and-configuration-webinar-training-703373-prdw?channel=Organic_Referral