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

Live Webinar on
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, July 12, 2011
10:00 AM PDT | 01:00 PM EDT

Register Now

Duration: 60 Minutes
Instructor: Jose Mora
Location: Online
Price : $245.00 (for one participant)

Instructor Profile:
Overview:
Jose Mora
Design History Files (DHF), Device Master Records (DMR), and Device
Principal Consultant, Atzari
History Records (DHR) are key building blocks used in the design,
Consulting, LLC
development, manufacturing, and cGMP compliance for the Medical
Device Industry.
JoseMora is a Principal Consultant

specializing in Manufacturing
Too often, these are cluttered, confusing, and cause many errors due
Engineering and Quality Systems.
to the way they are created, organized, and managed. This webinar
For over 29 years he has worked in
the medical device industry
applies the Theory of Lean Documents and also formulates a
specializing in manufacturing,
corresponding Theory of Lean Configuration to these key elements of
process development, tooling, and
medical device documents.
quality systems. Prior to working full

time as a consulting partner for
Areas Covered in the Session:
AtzariConsulting,Joseservedas
Director of Manufacturing
Engineering at Boston Scientific and
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Brief introduction to Lean Documents and Lean Configuration
as Quality Systems Manager at
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Quality System Regulation, 21 CFR Part 820, as it applies to
Stryker Orthopedics, where he
DHF, DMR, and DHR
introduced process performance,
problem solving, and quality system
l
Design History Files (DHF) content, development, and


methodologies. During that time he
management
prepared a white paper on the
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Device Master Records (DMR) content, development, and
application of lean manufacturing
management
methods to the creation and
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Device History Record (DHR) content, development, and
management of controlled
management
documents and a template for
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Applying lean principles to creating, developing, and managing
strategicdeployment.Joseledthe
a DHF
launch of manufacturing at a start-up
urology products company as
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Applying lean principles to creating, developing, and managing
Director of Manufacturing for
a DMR
UroSurge, Inc. at the University of
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Applying lean principles to creating, developing, and managing
Iowa's business incubator park in
DHRs
Coralville, IA, creating a world-class
medical device manufacturing
Click here to register for this webinar
operation, with JIT, kanban systems,
visual workplace and lean
manufacturing practices. ...more
Who Will Benefit:
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Managers, Supervisors, Directors, and Vice-Presidents in the
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areas of:
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R&D
Your Necessity is our Priority
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Manufacturing Engineering
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Quality Assurance
l
Operations
l
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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