3rd Annual Manufacturing Execution Systems

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A
CHOOSE FROM TWO PRE-CONFERENCE WORKSHOPS — TUESDAY, AUGUST 5, 2008
Unite Manufacturing and Quality Execution —
Achieving a Closed Loop Process
Innovators who are first to market are winners, but only if they can also be first to produce high quality products in increasing
volumes. New product introductions are a critical path and require manufacturing to remove obstacles such as variability due to
change and risks of inconsistent quality or even product failure. The new manufacturing and quality model is a platform that
unites Manufacturing Execution with Quality Execution, creating an end-to-end, closed-loop process that is predictive, proactive
and preventive. Combined with actionable intelligence, it provides early warning of process issues that can cause product
problems and root cause analysis that pin points the source of problems and enforcement of changes to prevent recurrence.
Attend this workshop to learn take-home strategies and techniques to implement this essential closed-loop manufacturing and
quality model to speed new product introductions, eliminate root causes of variability and reduce product and compliance risks.
7:30 Workshop Registration
8:30 Workshop Leaders’Welcome and Opening Remarks
I. The Traditional Role of MES
• Understand the investment you are making in MES,
and current industry best practices
• Recognize the disjointed relationship between MES
and Quality Systems, and the inherent limitations
• Review the dramatic increases in CAPAs, complaints
and recalls, and see how gaps in processes lead to them
II. The Manufacturing and Quality
Execution Vision
• Understand the principles of a closed-loop enterprise
manufacturing, quality and intelligence platform,
including the relationship of manufacturing process
and quality information to non-conformances, CAPA
and complaints
• Learn how predictive, proactive, preventive quality is
relevant to enterprise manufacturing
• New and effective ways to:
* enforce and verify manufacturing processes
for more effective change management and
issue prevention
* use pattern recognition for early warning and
visibility into process issues
* improve root-cause analysis to understand actual
cause and scope of non-conformances,
CAPAs and complaints
* ramp up new product introductions by quickly
improving quality
III. The Plan Forward — A Roadmap for
New Product Innovation with High Quality
• Learn the design and architecture of a closed-loop
manufacturing, quality and intelligence platform
• See specific examples of how to better enforce
manufacturing best practices, recognize patterns that
can lead to issues, quickly determine root cause of
problems and proactively prevent recurrences
• See how expanded intelligence can give you
real-time actionable data, pattern recognition,
root cause analysis and quick issue resolution
• Understand the plan and roadmap you can follow
to move from today’s siloed solutions to a
closed-loop manufacturing, quality and intelligence
execution platform
12:00 Close of Workshop A
There will be a 30-minute networking and refreshment break at 10:00 a.m.
— About Your Workshop Leaders —
Julie Fraser is Principal of Industry Directions, an analyst firm that
researches manufacturing and its value network. Ms. Fraser has over
twenty years experience as a manufacturing software advisor and marketer.
Prior to Industry Directions, she was Vice President of Marketing for
Baan Supply Chain Solutions, Senior Analyst at AMR and Editor of CIM
Strategies newsletter.
Karim Lokas is the Vice President of Marketing and Product Strategy at
Camstar where he leads Camstar's Industry Marketing, Marketing
Communications and Product Management teams. His responsibilities
include identifying market and customer needs, driving Camstar's corporate
brand and marketing strategy, managing the Master Product Roadmap for all
of Camstar's target verticals and defining product release requirements.
Mr. Lokas has extensive experience working with global manufacturers in
developing enterprise manufacturing and supply chain strategies and
solutions to drive operational excellence and innovation. A recognized
thought leader and frequent speaker at industry events, Mr. Lokas has been
quoted and published in numerous online and print publications such as MX,
Drug Delivery Technology, Medical Device Link and Managing Automation.
Mr. Lokas holds a Bachelors degree in Electrical Engineering and a Masters
degree focused on Bio-Medical Engineering.
Daniel R. Matlis is the Founder and President of Axendia, a trusted advisor
to Life-Science executives on business, technology and regulatory issues.
Mr. Matlis' eighteen years of experience in the life-sciences industry has
included projects in research and development, manufacturing, regulatory
compliance, business development and information technology. Prior to
founding Axendia, Mr. Matlis was Vice President and General Manager at
Stelex, Inc., a leading consultancy to life-science companies. He started his
professional career at Ethicon, Inc., a Johnson & Johnson Company.
He holds degrees from both Polytechnic University (BS in Electrical
Engineering) and New Jersey Institute of Technology (MS in Management).
Mr. Matlis is the chief contributor and editor of Life-Science Panorama,
a publication covering business, regulatory and technology issues facing
industry executives.