At the 8th Lean Six Sigma for Pharma, we will bring you real-world case studies that tackle the problems you are encountering, provide you with real-world solutions, and introduce you to industry peers who have been able to overcome many of the challenges Lean Six Sigma presents. Walk away with tools for practical applications of Lean Six Sigma in R&D, transactional, business and training processes as well as along the supply chain.

1. Register by
May 22nd &
8th Lean
Save up to
$1,896
Six Sigma
for Pharmaceutical, Over 18+
Biotech, and Medical case studies
and best
practices from
Device Excellence these leading
TM
companies:
Pfizer
Advanced Lean Six Sigma Techniques for
Wyeth
Optimizing Productivity, Profitability and
Cardinal Health
Reducing Costs
Genentech
July 27-29, 2009 Los Angeles, California Genzyme
Abbott
Baxter BioScience
Valeant Pharmaceuticals
Attend this event and return to work
with ready-to-use strategies on how to: Medtronic
Uncover best practices for successfully designing and implementing a Invitrogen
•
lean standard process for new product introductions
Amylin Pharmaceuticals
Gain valuable tools for initiating top-line approaches and senior
•
Johnson & Johnson
management buy-ins, while advancing sponsorship and leadership of
Lean implementation
Merck
Adopt new innovative approaches to furthering operational excellence
•
And many
capabilities such as business process Kaizen, integrating and aligning a
more….
culture through different sites and business units
Formulate and develop unique ways of applying and improving Lean Six Sigma
•
implementation within R&D and aligning your supply chain with your R&D customers
Media patners:
Expand your Operational Excellence capabilities and understand successful
•
collaborations between device manufacturer and client hospitals
Establish effective Lean Kaizen implementation as well as exceeding customers internal
•
needs, and effectively deploying Lean Six Sigma within your sales and marketing divisions
1-800-882-8684 • www.iqpc.com/us/lssp

2. Lean Six Sigma Who Will Attend?
8th Champions, Master Black Belts, Black,
Green, Yellow, & Red Belts, Executive /
for Pharmaceutical, Biotech, and Senior Vice Presidents, Vice Presidents,
Directors, Managers, and leaders of:
Medical Device Excellence July 27-29, 2009 • Process Excellence
TM
Los Angeles, California • Operational Excellence
Dear Colleagues, • Business Excellence
• Continuous Improvement
• QA/QC
IQPC’s 8th Lean Six Sigma for Phar
maceutical, Biotech and Medical • Development
Device Excellence is back
by popular demand.
• Manufacturing
• Engineering
At this event, we will bring you real- • Innovation
world case studies that tackle the
problems you are
encountering, provide you with real- • Validation
world solutions, and introduce you
to industry peers who have
been able to overcome many of the • Research & Development
challenges Lean Six Sigma presents.
Walk away with tools for
practical applications of Lean Six Sigm • Supply Chain
a in R&D, transactional, business and
training processes as well
as along the supply chain. • Logistics
• Maintenance
• Accounting
You will hear over 18+ in-depth
case studies and interactive sess • Packaging
ions including:
Implementing design for Six Sigm
•
a in medical and pharmaceutical prod • Information Technology
ucts
Initiating top-down approaches and
•
senior management buy-ins • Sales and Marketing
Driving operational excellence from
•
strategic planning to performance
measurement
Business process Kaizen implementati
•
on
Our Advisory Board
Implementing a Lean Six Sigma cultu
•
re into a new organization – and
ensuring sustainability
Bridging the gap and aligning your
•
Special thanks to the dedicated team of
supply chain with your R&D custo
mers advisors whose input provided continuous
improvement to the program!
Additionally, you will have the oppo
rtunity to attend a series of conferen • John Greer, Director of Continuous
ce workshops addressing
key issues such as implementing Lean
Six Sigma within sales and marketing Improvement, Bristol-Myers Squibb
divisions of your
organization, exceeding internal custo
mer needs, Lean Kaizen: A simplified • Kamal Nainani, Associate Director, Lean
approach to process
improvements and more.
Enterprise, Shire Pharmaceuticals
• Charles Aubrey, Vice President, Anderson
Engage in dynamic conversation with Pharmaceutical Packaging
your industry peers at our multiple
networking sessions, and
work closely with many LSS industry • Elizabeth Dare, Lean Sigma Black Belt,
experts. Additionally, this conferen
ce will include 4+ hours of
scheduled networking for engaging Clinical Business Office Director,
with conference speakers and peer
s from the pharmaceutical and
biotech industry. Be sure to regis AstraZeneca
ter yourself and a team of key peop
le for this important event today. • Mario Roman, Operational Excellence
Principal, Genentech
We look forward to seeing you in
Los Angeles in July! • Mark Hembarsky, Vice President, Technical
Services, Valeant Pharmaceuticals
Best Regards, • Georgette Belair, Vice President, Cross-
P.S. Enrich your experience Business Programs, Cardinal Health
• Alex Hsieh, ASQ-CSSBB, CQE, Principal
by attending our highly Scientist, Pfizer, Inc.
interactive and informative • Chad Moussa, Associate Director
Simon Curtis Strategy Excellence, Wyeth
pre-conference workshops! • Bruce Smith, Six Sigma Champion -
Conference Director
Manufacturing Central Groups, Eli Lilly
Six Sigma & Quality IQ, a divis
ion of IQPC
See page 5 for details • Ross Randolph, Master Black Belt,
Simon.curtis@iqpc.com
Program Manager for Business
Excellence, Abbott Vascular
• Ruben Ortiz, Senior Product Operational
Manager, Schering-Plough
Comments from IQPC’s past Lean Six Sigma for
Sponsorship & Exhibition
Pharmaceutical, Biotech and Medical Device Excellence Conferences:
Opportunities
“I thought this conference was very informative. I would recommend to others”
Sponsorships and exhibits are excellent
- Principal Business Consultant, AstraZeneca opportunities for your company to
showcase its products and services to high-
“Fantastic material and delivery!” - Project Manager, Baxter Healthcare
level, targeted decision-makers attending
“Very good insights into how to apply lean and Six Sigma to your organization.” the 8th Lean Six Sigma for
Pharmaceutical, Biotech & Medical
- Manager, Merck & Co., Inc.
Device Excellence. IQPC and Six Sigma &
quot;The atmosphere of true conference was extremely open and active - truthful discussions Quality IQ help companies like yours achieve
contributed to a deep (dive) into the critical success factors of Lean Six Sigma” important sales, marketing and branding
objectives by setting aside a limited number
- Business Intelligence Analyst, Eli Lilly & Co.
of event sponsorships and exhibit spaces –
“Very good conference: I really appreciate all of the help!” all of which are tailored to assist your
- Business Intelligence & Analytics Lead, Pfizer organization in creating a platform to
maximize its exposure at the event.
“This was my first IQPC Conference as I am new to Lean Six Sigma. This was an excellent
avenue for sharing information & best practices.” - Manager, GlaxoSmithKline For more information on sponsoring or
exhibiting at the 8th Lean Six Sigma for
“Incredible, receptive staff! Central location, very easily accessible” Pharmaceutical, Biotech & Medical Device
- Senior QA Auditor, Shire Pharmaceuticals Excellence, please contact Mario
Matulich at (212) 885-2719 or
sponsorship@iqpc.com.
1-800-882-8684 • www.iqpc.com/us/lssp
2

3. Conference Day One:Tuesday, July 28, 2009
Registration and Coffee Achieving Operational Excellence through
8:00
Methodology
Welcome Address and Chairman’s Opening
8:50
Remarks CASE STUDY: Operational Excellence: A
1:30
Collaboration Between Device Manufacturer and
William Botha, Director, Pharmaceutical Manufacturing & QLP,
Client Hospitals
Baxter BioScience
Becoming a “unique player” in the operational excellence arena
•
Initiating Top-Down Approaches Identifying a mutual interest and opportunity to initiate
•
and Senior Management Buy-Ins collaboration within the area of Operational Excellence
Discussing customer collaboration to increase efficiency and
•
PANEL DISCUSSION: Gaining Top-Down
9:00 reduce the operational costs
Executive Support for the Program Understanding how operational excellent tools are provided and
•
Driving the power of Lean Six Sigma from the executive level as delivered for customer satisfaction
•
a catalyst for change Steve Ebbing, Director of Operational Excellence, Cardinal
Discovering the major success drivers of successful Lean Six Health
•
Sigma deployment
CASE STUDY: Driving Operational Excellence
Understanding how management engagement and support 2:15
•
from Strategic Planning to Performance
connect with each of these drivers
Measurement
Determining how to best engage and leverage your executive
•
team to foster organizational alignment Building the right organization for accelerated change
•
Moderator: Mark Hembarsky, Vice President, Technical Services, How to develop and drive key metrics
•
Valeant Pharmaceuticals Assessing continual process improvement
•
Panelist: Mario Roman, Operational Excellence Principal, Deploying a culture of continuous improvement and a strategy
•
Genentech for change through a foundational strategic planning process,
the tools of Lean Six Sigma, DFSS, PAT, PMM and a
Sponsorship and Leadership of Lean
9:45 comprehensive assessment process
Implementation Internally William Botha, Director, Pharmaceutical Manufacturing & QLP,
Achieving senior management buy-in for LSS Baxter BioScience
•
Gaining middle (line support/manager) management
•
Afternoon Networking Break
engagement 3:00
Build grass roots support: Utilize Kaizens to engage the
•
Value Stream Mapping to Extract Value from ERP
workforce and build acceptance with middle management 3:30
Systems
Getting functions outside supply chain to buy-in to Lean, and
•
pull our expertise in to their world Looking at opportunities within the product value stream
•
Formulating an appropriate leadership plan post buy-in Taking into consideration the question “what value does the
• •
Bill Stinchcomb, Associate Director, QA Process Improvement, customer seek?”
GPRD, Abbott Enabling suitable methods to map out the supply chain and
•
supporting activities necessary to move each product from
Morning Networking Break
10:30 design to production to delivery
Benefit from value stream mapping by finding ways to eliminate
•
Design for Six Sigma (DFSS) waste and unnecessary steps from the supply chain to
production
CASE STUDY: Implementing Design for Six Sigma
11:00 Displaying the successful measurement and analysis of Kaizen
•
in Medical and Pharmaceutical Products Event deployment planning and impacts
Leveraging synergy between DFSS and Quality by Design in a Marc Cromer, Six Sigma Black Belt, Senior Manager Global Quality
•
FDA regulated environment Validation, Invitrogen
Creating pull from development teams, scientists and engineers
•
CASE STUDY: Business Process Kaizen
Generating pull from senior executives and leadership 4:15
•
Implementation
Discussing medical instrumentation
•
Uncovering pharmaceutics Quality by Design Overview of Kaizen tools
• •
Georgette Belair, Vice President, Cross-Business Programs, Selecting transactional processes
•
Cardinal Health Discussing risk from a compliance regulatory/FDA perspective
•
Identifying project risk at the Kaizen level
•
Networking Lunch
11:45 Building grass roots support: Utilize kaizens to engage the
•
workforce and build acceptance with middle management
CASE STUDY: PAT Deployment Strategy Over an
12:30 Renee Cvekus, Regulatory/Quality Systems - Process Improvement,
Existing Foundation of Lean Six Sigma Medtronic CardioVascular
Demonstrating how Baxter’s PAT vision ties into the existing
•
Chairman’s Closing Remarks and End of Day One
Operational Excellence strategy 5:00
Developing adequate operating mechanisms, deployment
•
structure, and standard tools and templates to drive progress
and harmonization
Defining the metrics and measuring the progress
•
Serj Vartanian, Global Quality Systems Manager, MBB, BioScience,
Baxter Healthcare Corporation
1-800-882-8684 • www.iqpc.com/us/lssp
3

4. Conference Day Two:Wednesday, July 29, 2009
Registration and Coffee Lean Six Sigma Implementation within R&D
8:00
Welcome Address and Chairman’s Opening Applying and Improving Lean Six Sigma
8:50 1:30
Remarks Implementation Within R&D
Determining how risk management and Lean Six Sigma can
•
Mastering Lean Six Sigma and Process Excellence to work simultaneously and streamline R&D processes
Maximize Organizational Goals Unearthing efficient strategies for measuring sustainable
•
operational improvements for your organization
OPENING KEYNOTE: Implementing a Lean Six
9:00 Identifying waste elimination strategies within your R&D
•
Sigma Culture into a New Organization – and processes – Displaying case study examples
Ensuring Sustainability Discovering the most effective value stream strategies and
•
Aligning your LSS program with the company business strategy projects to choose
•
Implementing a LSS culture with an aligned approach globally Valuing efficiency and effectiveness in R&D
• •
Preparing and executing a culture shift – key aspects to consider David Rodin, Director, Operational Excellence, Merck & Co., Inc.
•
Driving awareness and understanding across multi-disciplinary
•
Bridging the Gap and Aligning Your Supply
divisions 2:15
Chain with Your R&D Customers
Using training and learning to build capability
•
Ensuring sustainability of results Determining how risk management and Lean Six Sigma can
• •
Wendy A. Kouba, Vice President, Operations Management, work simultaneously and streamline R&D processes
Operational Excellence, Wyeth Understanding the need to align supply chain and production
•
processes with our R&D customer needs
Morning Networking Break
9:45 Unearthing approaches for measuring sustainable operational
•
improvements for your organization
CASE STUDY: Lean Transformation and the Next
10:30 Working backwards from the customer requirements to deploy a
•
Steps process capable of routinely meeting them
Building a management framework to support the multi year Converting from a make-to-stock commercial model to a make-
• •
lean journey to-order custom job shop
Aligning and focusing the organization using Strategy Robert Bottome, Director, Operational Excellence, South San
•
Deployment Francisco Production, Genentech
Lean Maturity Assessment and selection process
•
Afternoon Networking Break
Driving execution discipline with MDI and RALFI 3:00
•
Displaying successful lean transformation examples within
•
CASE STUDY: Applying Lean Six Sigma (LSS)
Genzyme 3:30
Tools to Increase Clinical Manufacturing Capacity
Frank Sivo, Director, Global Lean Transformation, Genzyme
Using a systems perspective to proactively identify initiatives that
•
Delivering and Sustaining Lean on the Shopfloor
11:00 enable R&D strategic objectives
Uncovering three elements of Wyeth’s transformation – Technical application of LSS tools to reduce product changeover
• •
Operating system, management infrastructure and mindsets & cycle times for the clinical manufacture of monoclonal
behaviors antibodies
Delivering transformational change Employing risk assessment to challenge internal specifications
• •
Generating rapid results while using GEMBA to build your and testing requirements
•
team's capabilities and sustain improvements Derek Greene, Lean Six Sigma Black Belt, Research and
Sustaining continuous improvement – Focusing on management Development, Pfizer
•
infrastructure
Analyzing Lean Applications in a Manufacturing
Senan Griffin, European Operational Excellence Manager, Wyeth 4:15
Environment
Networking Lunch
11:45 Integrating the lean and agile manufacturing paradigms in the
•
total supply chain
Ensuring Company Wide Commitment to Process
12:30 Analyzing key factors including just-in-time (JIT), total quality
•
Improvement management (TQM), total preventive maintenance (TPM), and
Effectively training and motivating large numbers of people human resource management (HRM).
•
Understanding the principles of continuous improvement Understanding their effects on operational excellence
• •
Going beyond buy-in from your operational directors to taking Understanding a DMAIC Kaizen deployed for the shop floor
• •
responsibility for quality and efficiency within their working Discussing a DMAIC approach to Class A
•
practices and departments Bruce Sawyer, Vice President, Global Business Excellence, GPSG,
Moving Lean Six Sigma from a departmental consulting position Johnson & Johnson
•
to the way the entire company carries out its day job
End of Conference & Chairman’s Closing remarks
Creating the balance between centralized Lean Six Sigma teams 5:00
•
and Lean Six Sigma project leaders based in the business
Alan Bradshaw, Director, Operational Excellence, Amylin
Pharmaceuticals
1-800-882-8684 • www.iqpc.com/us/lssp
4

5. Pre-Conference Workshops: Monday, July 27, 2009
9:00am-11:00am (Registration at 8:30am) Coffee will be served
A Using Lean Six Sigma for Exceeding Internal Customer Needs
Every interaction with a customer is an opportunity for advancing your relationship and Benefits of attending:
gaining key information. Your early interaction efforts set the stage for mature and productive Hear beyond Voice of the Customer: What are the essential requirements they need from
•
relationships. In the Measure phase of the Six Sigma DMAIC improvement methodology, data you?
is collected and analyzed to provide a performance baseline for the process under study. This Identify strategies for keeping up with market trends in OE
•
workshop will show how lean and Lean Six Sigma are applied and leveraged to exceed Ascertain how to align your OE strategy to corporate goals
•
customer needs, improve customer satisfaction, and maximize customer relationships. Discover how Lean and Lean Six Sigma are applied and leveraged to exceed customer needs
•
What will be covered; Understand how to improve customer satisfaction internally
•
Understand Customer Value in improvement
•
Recognize strategies for maximizing customer relationships
•
Include Voice of the Customer in all processes
•
Workshop Leader: Jeff Cisneros, Global Technology, Operational Excellence Manager,
Develop systems to quantify feedback Training and Methodology, Genentech
•
Involve the customer in improvements
•
Share improvements with customer
•
11:45am-1:45pm (Registration at 11:15am) Lunch will be served
B Lean Kaizen: A Simplified Approach to Process Improvements
Lean Kaizen is powerful tool to transform culture and improve processes. It develops the Benefits of attending:
quot;Kaizen Mindquot; in all of your employees. The idea is that everyone in an organization Discover why small changes yield big results in quality, productivity and customer service
•
reexamines their work and improves it in small ways within their control. Understand why small changes are so easy and fast
•
What will be covered: Learn about turning ideas into success
•
Definitions and principals of Kaizen Why changing the method improves the process
• •
Essential steps and obstacles to a Creative Idea System Find out how to track, report and reward Quick & Easy Kaizen efforts
• •
Elements and rules of a Kaizen System Workshop leaders:
•
Stages of development Mario Roman, Operational Excellence Principal, Genentech
•
Benefits of Quick & Easy Kaizen System
•
2:30pm-5:30pm (Registration at 2:00pm)
C Implementing Lean Six Sigma within Sales and Marketing Divisions of Your Organization
What will be covered: Benefits of attending:
Increasing profitability by driving the top line of the business (revenue), more than just Learn how to implement Operational Excellence within your sales and marketing
• •
driving down expenses Understand how to utilize Lean Sigma to meet critical customer needs and ensure effective
•
Successfully implementing Lean and Six Sigma in sales and marketing divisions of your utilization of scarce resources
•
organization Learn how leading companies have used Lean Sigma to generate substantial business benefits
•
Understanding and discovering which opportunities are best suited for applying Lean Six Discover best practices and critical success factors that help overcome resistance to change
• •
Sigma in sales and marketing Become exposed to real case studies and examples for how to utilize Lean Sigma to drive the
•
Applying Lean Sigma to improve Sales force efficiency and effectiveness top line
•
Developing innovative value propositions and harnessing stronger customer relationships Workshop leaders:
•
Engaging sales and marketing leadership effectively to minimize resistance Thomas Bertels, Partner, Valeocon Management Consulting
•
Discovering how LSS can help meet the needs of critical stakeholders such as insurance Dick Smith, Executive Advisor, Valeocon Management Consulting
•
providers and regulatory bodies
6:00pm-8:30pm (Registration at 5:30pm)
D A Practical Guide for Obtaining Company-Wide Support of Lean Six Sigma Initiatives
The tools of Lean Six Sigma create a degree of organizational capability and challenge the way Quantifying the costs outstanding and the aging of the debt
•
work is currently done. In addition to understanding this capability, customer and culture are Making a simple cost-of-poor-quality calculation based on your companies investment income
•
two other critical components that must be managed within your organization to enable assumptions
enterprise execution. Many leaders fail to see the big picture – plan, involve, communicate, Turning this into a performance dashboard to maintain focus and show progress
•
train, understand responsibility and encourage. Instead they settle for quot;tool-driven project Benefits of attending:
success,quot; never achieving enterprise-wide change and strategy execution. This discussion will Discover how to request support from the person who heads the organization
•
provide an overview of how to align leadership efforts to enable organization-wide execution Review past projects where there are buy-in issues
•
of the Lean Six Sigma approach. Creating a shared need or common vision with black belts and process owners
•
What will be covered: Understand appropriate approaches to senior management for supporting your lean initiatives
•
The importance of collecting output metrics (Ys) on the process Workshop Leader: Praveen Gupta, Management Consultant,
•
Showing the extent of the problem and you can use it to get management attention Accelper Consulting
•
Registration Information
Please see website for explanation of DETAILS FOR MAKING PAYMENT VIA EFT OR WIRE
Qualified Pharmaceutical, Biotech and Medical Device Organizations: Qualified Pharmaceutical, Biotech and TRANSFER:
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YES! Please register me for New York, NY 10017
Lean Six Sigma
8th
for Pharmaceutical, Biotech, and
Medical Device Excellence TM
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Register by
8th Lean May 22nd &
Save up to
Six Sigma $1,896
for Pharmaceutical,
Biotech, and Medical “The conference
was well facilitated
– the help was
Device Excellence TM
exceptional, nice
environment!” - Director
of Strategy, Wyeth
Advanced Lean Six Sigma Techniques for Pharmaceuticals
Optimizing Productivity, Profitability and “Please continue these! Very
Reducing Costs useful in these hard economic
times” - Senior Advanced
Manufacturing Engineer, DSM
July 27-29, 2009 Los Angeles, California Pharmaceuticals