Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration

  • Speaker:Jose Mora
  • Date: 16th March 2016 10:00 AM PST | 01:00 PM EST
  • Duration:90Min
  • Product Code:GRC-90011

$209

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Live Session - How it works

  • Username and Password will be sent to you 24 hours prior to the webinar.
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Recorded Session - How it works

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Training CD - How it works

  • Free shipment within 72 Hours, from the date of webinar completion.

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Why should you attend:

Medical Device managers, engineers, QA personnel, as well as lean program leaders.

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 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: 

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

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

Target  Audience: 

Design Engineers, Design Assurance, Quality Assurance

Available Options

Recording: Access it for 6 months from any location

$209

CD: Shipped within 2 working days

$339
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