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

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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, December 13, 2011
10:00 AM PST | 01:00 PM EST

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
Why you should attend:
AtzariConsulting,Joseservedas
Director of Manufacturing
Do you find yourself constantly struggling to create, manage, and
Engineering at Boston Scientific and
maintain all of the information found in DHFs, DMRs, and DHRs -
as Quality Systems Manager at
which is often redundant, repetitive, and chained together in a
Stryker Orthopedics, where he
cumbersome way? Do you find that your design and manufacturing
introduced process performance,
resources are spending way too much time on documentation and
problem solving, and quality system
methodologies. During that time he
not enough on engineering and design?
prepared a white paper on the
Areas Covered in the Session:
application of lean manufacturing

methods to the creation and
management of controlled
l
Brief introduction to Lean Documents and Lean Configuration
documents and a template for
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Quality System Regulation, 21 CFR Part 820, as it applies to
strategic deployment.Joseledthe
DHF, DMR, and DHR
launch of manufacturing at a start-up
l
Design History Files (DHF) content, development, and
urology products company as
management
Director of Manufacturing for
UroSurge. ...more
l
Device Master Records (DMR) content, development, and
management
l
Device History Record (DHR) content, development, and
management
Suggest a Topic
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Click here to register for this webinar
Who Will Benefit:
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Managers, Supervisors, Directors, and Vice-Presidents in the
areas of:
l
R&D
l
Manufacturing Engineering
l
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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