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Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) – Principles on Lean Documents and Lean Configuration

Date & Time: Tuesday, December 13, 2011

10:00 AM PST | 01:00 PM EST

Duration: 60 Minutes

Instructor: Jose Mora

Location: Online

Price : $245.00

 

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Instructor Profile:

Overview:

Jose Mora Principal Consultant, Atzari Consulting, LLC

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. This webinar applies the Theory of Lean Documents and also formulates a corresponding Theory of Lean Configuration to these key elements of medical device documents.

Why you should 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?

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Brief introduction to Lean Documents and Lean Configuration Quality System Regulation, 21 CFR Part 820, 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

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 29 years he has worked in the medical device industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as  Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. José led the  launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge. ...more

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Operations Document Control

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel


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Design History File (DHF), the Device Master Record (DMR) and theDevice History Record (DHR)  

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, develo...

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