"Creation of DHFs, DMRs, and DHRs utilizing the principles of

Lean Documents and Lean Configuration"

Industry: Medical Device
Speaker: Jose Mora
Product Code: CP2014-389
Wednesday January-14-2015 01:00 PM | 02:00 PM - EDT , 60 Minutes

DESCRIPTION
The Theory of Lean Documents is the product of applying lean principles to the creation,
design, process, and management of controlled documents typically found in regulated
industries. Just as lean principles challenge traditional process concepts and "push"
systems, many traditional document practices are artifacts of a flawed approach. Lean
documents presents a fresh departure from these practices, while building upon proven
principles. Lean configuration comes from the same principles, utilizing the unique
power of software solutions to take over functions that had previously burdened controlled
"paper" documents.

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

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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

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Manufacturing Engineering
Design Assurance
Quality Assurance
Operations
Document Control

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides
60 Minutes Live Presentation
Certificate of Attendance

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Availabe Purchase Formats:

LIVE

$189

One Dial In - One Attendee

$249

One Dial In - Unlimited attendance (To be

arranged in a Conference room/Meeting
room. Note : Only One Dial In Allowed)

COMBO

$329

Combo 1 (One Dial In - Unlimited

attendance + On Demand Recorded
Session)

$349

Combo 2 (One Dial In - Unlimited

attendance + Training CD)

RECORDED

$239

On Demand ( 90 Days of online Streaming

access available after the live session )

$279

Play Back - Unlimited Views ( Recorded

file available for download after the live
session )

$299

Get Training CD

MULTIPLE LOCATION

$499

Multiple location - Up to 5 Dial in allowed

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About the Speaker

Jose Mora
Job Title: Consultant
Industry: Medical Device
Country: United States of America

Jos Mora is a Principal Consultant specializing in Manufacturing Engineering and

Quality Systems. For over 30 years he has worked in the medical device and life sciences
industry specializing in manufacturing, process development, tooling, and quality systems.
Prior to working full time as a consulting partner for Atzari Consulting, Jos 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. Jos led the launch of
manufacturing at a start-up urology products company as Director of Manufacturing for
UroSurge, Inc. at the University of Iowas business incubator park in Coralville, IA,
creating a world-class medical device manufacturing operation, with JIT, kanban systems,
visual workplace and lean manufacturing practices. Jos worked for 10 years at Cordis
Corporation, now a Johnson & Johnson company, where he led the successful tooling,
process development and qualification of Cordis first PTA (percutaneous transluminal
angioplasty) catheter. His medical device experience includes surgical instruments, PTA &
PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders,
urology implants and devices for the treatment of incontinence, delivery systems for
brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and
textiles. During his time at Cordis, Jos managed the Maintenance and Facilities
Department, taking that operation to a level rated as tops by the UK Department of
Health and Social Services (DHSS) during one of their intensive audits. Jose managed
Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a
team that took the Cordis Guiding Catheter business to lead the market, bringing it up
from fourth place. By introducing world-class techniques, the Guiding Catheter design and
manufacturing was completely re-engineered for robust design and tooling, under Joses
leadership. He was also instrumental and played a leadership role in the complete reengineering of the Tooling Control System, including design drafting, the tool shop and

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technical support. Wherever he has worked, he has a track record of introducing worldclass methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints,
Lean Manufacturing, Five S (Visual Workplace), process validation to Global
Harmonization Task Force standards, and similar approaches..

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