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Jos Mora

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Webinar Description:
Areas Covered in the Session :
Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History
Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration
Product Id MD1048
Category Medical Devices
Scheduled On Wednesday, August 6, 2014 at 13:00 Hrs
Duration 60 Minutes
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 present 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.
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 must attend webinar presents a fresh new approach based upon solid principles and proven practices - as
well as an alternative, applies the Theory of Lean Documents and also formulates a corresponding Theory of Lean
Configuration, that avoids many of the pitfalls of traditional ways of preparing these Key Regulatory Documents.
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

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Speaker Profile:

Who Will Benefit:
A must for all Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
Manufacturing Engineering
Design Assurance
Quality Assurance
Document Control
Lean Program Leaders
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 re-engineering of the Tooling Control System, including design drafting, the tool
shop and technical support. Wherever he has worked, he has a track record of introducing world-class
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.