An Advanced course on Lean Documents and Document Control

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Organized by OnlineCompliancePanel
By José Ignacio Mora
Live on Friday, September 5, 2014 at 0230PM
EST
Registration Fees 206 per attendee
Registration Link http//bit.ly/LeanDocuAndDocuC
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OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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An Advanced course on Lean Documents and Document
Control
In this Lean Documents and Document Control
training learn the different types of lean
documents and the usage of lean document
principles types of controlled documents
examples of lean and non-lean controlled
documents. Pros and cons of lean vs. non-lean
documents.
Why Should you AttendJust as a manufacturing
process produces a product, controlled documents
are the product of a business process. Just as in
manufacturing, a product cannot move forward if
it is waiting for component parts, a document
cannot move forward if it is waiting for
information, or if its use is constrained by
other documents. Although many life science
companies advocate lean manufacturing, lean
laboratory, and lean operations, they have
cumbersome controlled documents and systems which
cause significant operating expenses, and make it
difficult to introduce process improvements in a
timely manner.This webinar presents key
concepts on introducing lean principles, while
maintaining a state of control and regulatory
compliance. It will help you understand applying
lean manufacturing principles, theory of
constraints, DHF, DMR, DHR and how to create a
lean DHF, DMR, DHR.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
3
An Advanced course on Lean Documents and Document
Control

• Objectives of the Presentation
• Definition of lean documents.
• Problems with traditional document approach.
• Applying lean manufacturing principles.
• Applying Theory of Constraints.
• Design History File.
• Device Master Record.
• Device History Record.
• Typical challenges and how to overcome them.
• Examples of various types of lean documents.
• Use of lean document principles types of
  controlled documents examples of lean and
  non-lean controlled documents. Pros and cons of
  lean vs. non-lean documents.
• How traditional document approach generates
  waste.
• Clues from Theory of Constraints and Lean
  Manufacturing.
• What a lean document approach would have.
• Creating a lean Design History File.
• Creating a lean Device Master Record.
• Creating a lean Device History Record.
• Preparing for an electronic document system.

OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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José Ignacio Mora Principal Consultant
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
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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About OnlineCompliancePanel Online Compliance
Panel creates and delivers comprehensive industry
relevant training sessions. These sessions are
simple, interactive and cost effective. We are a
predominantly web based information exchange
forum. Live interactions on compliance training
make the process holistic and effective. Online
Compliance Panel largely emphasizes in offering
regulatory compliance training to compliance
professionals on varied topics. These primarily
include risk management, quality management,
corporate compliance and other regulatory
compliances. Some of our primary areas of focus
include advancement and updates in regulatory
compliance, best practices and market trends.We
strive to incorporate high standards in
developing a culture facilitating exchange of
ideas resulting in functional excellence. Online
Compliance Panel believes in nurturing ideas and
thought processes through innovative e-learning
methodologies. Our products and services are
designed to offer customized solutions to
industry and market. We bridge the gap between
experience and knowledge thus delivering original
and creative content.Our objectives of
employing interactive mediums ensure effective
communication and mutual exchange of ideas.
Online Compliance Panel closely follows best
practices and regulatory trends in the global
compliance scenario. We also observe and
communicate trends witnessed in FDA, ISO
regulations, process and design validation. All
updates and additions to important laws can be
accessed by our customers in real time.Our
mission is to empower compliance professionals
through effective online training sessions. Our
world class training methodologies stem from
comprehensive understanding of client
requirements. The content conforming to FDA and
ISO standards is developed by well qualified and
experienced industry leaders. Our offerings will
exceed expectations and add value to your
investment.The content in various categories
such as medical devices, pharmaceuticals and
biotechnology will raise the bar in terms of
quality already on offer .We hope to contribute
to the creation of responsible organizations
creating benchmarks in quality, integrity and
transparency.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com