Webinar On 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

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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 1300 Hrs
Duration
60 Minutes
José Mora
Speaker
To visit our website
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Webinar 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 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.
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

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Who Will Benefit

• A must for all Managers, Supervisors, Directors,
  and Vice-Presidents in the areas of
• RD
• Manufacturing Engineering
• Design Assurance
• Quality Assurance
• Operations
• Document Control
• Lean Program Leaders

Speaker Profile
José 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, 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, 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. José 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, José 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.

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