Lean Six Sigma

for Pharmaceutical
and Biotech
Manufacturing
Excellence
Increasing Productivity, Efficiency and
Customer Satisfaction with Lean and Six
Sigma Techniques

February 27-March 1, 2006

Doubletree Hotel Philadelphia
Philadelphia, PA

Strategies to be Discussed Include:

Tools to Improve and Sustain

Your Lean Six Sigma
Deployment Through DFLSS
Capabilities
Successfully Applying Lean
Six Sigma Principles to
Inventory Controls

Featuring Best Practice

Case Studies from these
Leading Organizations:
INVITROGEN, USA
JOHNSON & JOHNSON
SCHERING-PLOUGH
CORPORATION
AMGEN INC.
SAVIENT
PHARMACEUTICAL
TAP PHARMACEUTICAL
PRODUCTS INC.
NOVAVAX, INC
BAXTER BIOPHARMA
SOLUTIONS
CENTOCOR
PRTM MANAGEMENT
CONSULTANTS
BAYER TECHNOLOGY
SERVICES
Dont Miss the Highly
Interactive Workshops By:
PHARMATECH
ASSOCIATES
OMNEX, INC
SIX SIGMA
PROFESSIONALS, INC.
The author of SIX SIGMA
SIMPLIFIED, LEAN
SIMPLIFIED

A Case Study on How to Successfully Deploy Lean

How to Reduce Rework & Eliminate Deviations

While Continuing to Maintain Compliance and
Quality

Reducing Cycle Times Through Labor Flexing and

Workload Leveling

Media Partners:

Register today! Visit www.iqpc.com/PharmaIQ Call 1-800-882-8684

Dear Executive:
"Despite recent advances, the pharmaceutical
industry remains behind other industries in terms
of process efficiency. With ever-mounting costs,
thinning pipelines, and demands for price control,
the industry is looking for other methods to stay
competitive and drive process improvement"
(Pharmaceutical Processing)
Lean Six Sigma is the answer: "Lean and Six
Sigma work together, achieving results
consistently superior to what either system could
achieve alone." (Quality Progress, April 2003)
Therefore, dont miss the unique opportunity to
benchmark and learn how Lean Six Sigma really
applies to your organization wherever you are on
the Lean and Six Sigma journey and attend Lean
Six Sigma for Pharmaceutical and Biotech
Manufacturing Excellence Conference
February 27 March 1, 2006 in Philadelphia.
This conference is full of how-tos and watch-outs.
It was designed for you by your peers. You wont
find a better place to learn how successful
organizations are managing their process and
quality improvment!
With two days filled with outstanding
presentations designed to generate tools ready
for implementation in your organization, multiple
workshops packed with useful innovative
strategies as well as ample networking
opportunities, you cannot afford to miss this
event! Mark your calendar for February 27
March 1, 2006. Call 1-800-882-8684 to reserve
your seat today!
See you in Philly!

Izabella Rychlik
Conference Director
IQPC

P.S. To maximize your

learning potential, make
sure to check out our
pre conference
workshops!

Who Will Attend & Benefit

From This Conference:
Vice Presidents, Directors and Managers
involved in the following areas:
Manufacturing
Lean Manufacturing / Lean Implementation
Operations
Manufacturing Business Development
Manufacturing Engineering Manager
Manufacturing Alliances
Six Sigma
Process Excellence
Operational Excellence
Quality Assurance / Quality Control
Quality Improvement
Production Manager
Risk Management
Regulatory Affairs
Project Management
Validation
Process Development / Process Engineer
Supply Management / Supply Chain

Pre-Conference Workshops:
Monday, February 27th, 2006
Workshop A 8:00am 11:00am

7:30am Workshop Registration Breakfast will be served

Applying Lean Manufacturing to your Organizations Process Excellence

Program in the Pharmaceutical and Biotech Industry
Many organizations have embraced the continuous
improvement programs such as TQM and Six Sigma
through the development of a formalized Process
Excellence program. Lean manufacturing is Quality
philosophy that can greatly strengthen the effectiveness of
an organizations process excellence initiative. Lean
manufacturing concentrates on minimizing the
consumption of resources that add no value to the finished
product. This is achieved by optimizing those processes
that bring value to your product thereby eliminating
wasted time, money, and productivity.
Topics covered in this workshop include:

Workshop B 11:15am 2:15pm

Differences between Six Sigma and Lean Manufacturing

Lean deployment challenges for process driven industries
How to identify and define the Value Stream
Tools for optimizing the Value Stream and how to
apply them
How to deploy "Kaizen teams" and how to achieve
breakthrough improvements
Metrics for describing a lean organization

Your Workshop Leader:

Bikash Chatterjee, Chief Operating Officer,
Pharmatech Associates Inc.

11:00am Workshop registration lunch will be served

Lean Six Sigma Simplified

If you want to jumpstart your Lean Six Sigma efforts or
revive a lumbering Lean Six Sigma program, this workshop
is for you. Lean and Six Sigma are two proven approaches
to systematically reducing defects, delay and costs that will
boost both your productivity and profitability. This
simplified approach to Lean Six Sigma recognizes that only
a few key methods and tools are necessary to solve most
of your problems. And it doesnt have to take forever.
Many Lean Six Sigma projects can be analyzed in a matter
of hours or days, not months or years. So, bring your
laptops and Excel spreadsheets with data from about the
defects, delays or costs that plague your companys
performance. The goal is for you to create actionable
improvement projects in this workshop.
This interactive workshop will teach you how to:

Understand Lean Six Sigma and what it can do to cut

costs and boost profits

Workshop C 2:30pm 5:30pm

Understand how to implement Lean Six Sigma using a

crawl-walk-run approach that will, surprisingly, maximize
your benefits while minimizing your risks and costs

Understand how to laser-focus your improvement

teams for breakthrough results

Understand how to use a few key methods and tools

required to drive breakthrough improvement in your
mission critical processes
Materials Provided to Each Participant:

Six Sigma Money Belt Action Plan

Lean Simplified Book (128 pages)

Lean, Six Sigma Simplified and SPC Quick Reference Cards

QI Macros SPC Software for Excel 30-day evaluation

Your Workshop Leader:

Jay Arthur, Author of Six Sigma Simplified, Lean
Simplified and the creator of the QI Macros for Excel

2:15pm Workshop registration

Utilizing Lean Design for Six Sigma to Improve Your Companys

Overall Performance
In the majority of cases, there are differences between a
companys current performance and aspired targets. A
principle-centered approach to Lean Six Sigma and Lean
Design for Six Sigma are strategies for improving the value
proposition at present and future times of companies
experiencing such a gap between aspiration and
performance. Deployment of principle-based Lean Six
Sigma and Lean DFSS at the project level is the best
strategy to attack the root causes of such differences.
In this workshop learn how to:

Develop the principle-centered approach to Lean Six

Workshop D 5:45pm 8:45pm

Sigma and Lean Design for Six Sigma most suited to

pharmaceutical industry
Highlight the application, activities and outcomes of
such approach
Concentrate on deployment aspects for start-up
companies and well-progressed Companies in the Six
Sigma endeavor

Your Workshop Leader:

Dr. Basem Haik, CEO, President
Six Sigma Professionals, Inc.

5:30pm Workshop registration dinner will be served

Strategic Lean Six Sigma: Receiving Results that are Most Important
to Your Business
Today Lean And Six Sigma are no longer just about simply
reducing waste, quality and consistency within isolated
projects. It is about improving your entire business. By
applying a business-oriented approach to your initiative,
strategic Lean and Six Sigma can become an essential
foundation to assure that businesses units consistently
achieve their key strategic goals within their day to day
operations and selection of Lean and Six Sigma projects
and resources. This workshop will show you how Lean Six
Sigma can help your teams deliver a far greater return on
investment and achieve deeper executive support much
sooner in your initiative.

This workshop will teach you how to:

Focus project selection to key business objectives

More closely integrate Lean objectives across multiple

business initiatives

More effectively engage key executives and business

unit leaders

Improve customer services and loyalty

Implement DIKAR (Data-Information-KnowledgeActions-Results)

Your Workshop Leader:

Glenn Kubisiak, Senior Consultant, Omnex, Inc.

Lean Six Sigma for Pharmaceutical and Biotech Manufacturing Excellence

Philadelphia, PA

Main Conference Day 1 Tuesday, February 28, 2006

7:30

Registration

8:15

Chairpersons Welcome and Opening Remarks

8:30

Determining the Future of Pharmaceutical

Manufacturing and the Role Played by Lean
and Six Sigma

In this provocative presentation you will discover a framework that will help
you understand the future of the pharmaceutical industry from an
operations/manufacturing perspective. This framework has been very
accurate in describing the evolution (and predicting the future) of many
industries, including the pharmaceutical industry. The presentation will
explore how the role of operations will change over the next 10 years and
answer why Lean and Six Sigma programs are strategic in nature.
In this session you will learn how to:
Develop a viewpoint on the future structure of the biopharmaceutical industry
Understand the role of pharmaceutical manufacturing within this new
industry structure
Learn how operations can become a competitive advantage
Take advantage of Lean and Six Sigma to improve the overall outcome
Determine what it will take to succeed (and indeed thrive) as a leader in
operations
Explore the key metrics in determining progress
Mr. Jan Paul Zonnenberg
Partner, Life Science
PRTM MANAGEMENT CONSULTANTS

9:20

Successful Deployment of Lean at Amgen

Amgen has developed a lean deployment strategy that took into

consideration the relative youth of biotechnology, Amgens unique culture,
and the recommendations of Lean experts. The team showed several
million dollars in savings in the first six months and created enough positive
momentum to widen the net in year two. This presentation highlights the
importance of customizing Lean deployment for the realities of your
industry and your organization. One size does not fit all.
Learn how in:
Year one to: Establish the function, keep it simple and show good results
Year two to: widen the net, add floor-focused lean and couple critical
organization metrics with Lean deployment
Chris Driscoll
Associate Director, Quality Assurance
AMGEN INC.

10:10

Networking and Refreshment Break

10:40

Schering-Ploughs Version of Six Sigma "SIP"

(Supply Improvement Process) Provides the
Model for Transformational Change as the
Enabler of "Right First Time"

An innovative improvement process methodology has turned into a

powerful tool thats helping drive transformational change at ScheringPlough facilities around the world. The Supply Improvement Process, known
as "SIP", is providing a pathway to achieve robust process design and
executional excellence through continuous improvement. The "SIP"
methodology is Schering-Ploughs novel approach to quality continuous
improvement that includes the tools and principles of Six Sigma, Quality
Management Systems and the regulatory requirements to sustain and
enhance Schering-Ploughs compliance position.
In this session learn how to:
Take a systems-thinking approach to improving processes to exceed the
requirements of Global Quality Operations and the Global Supply Chain
Provide the necessary structure, common language, focus, consistent
approach and control to analyze and challenge processes to remove
waste
Reduce rework and eliminate deviations, while continuing to maintain the
highest standards of compliance and quality
Robert Sparadoski
Director, Quality Management and Planning
SCHERING-PLOUGH CORPORATION

11:30

Applying Lean - Sigma Principles in Pharma R&D

Pharmaceutical companies are challenged to design and develop more

compounds faster, in a complex environment while reducing cost and
maintaining or improving quality. TAP Pharmaceuticals Products Inc.,
addressed these issues by adapting "Lean" and "Six Sigma" principles
within R&D. Find out how the partnership between Lean and Six Sigma is
helping R&D achieve Operational Excellence. How to reengineer
development processes to reduce variation and defects while improving
quality and how to apply Lean-Sigma principles in your company
This presentation addresses:
Adapting the concept of Lean and Six Sigma to Pharma R&D
Structuring R&D to facilitate application of the Lean-Sigma model
Comparing drug development to manufacturing: key differences and
complexities
Lean Six Sigma a few concepts explained
Initial Success
Rama Shankar, MS, Engineering Management, CSSBB
Quality Performance Manager
TAP PHARMACEUTICAL PRODUCTS INC.

12:20

Luncheon for Speakers and Delegates

1:20

PANEL DISCUSSION: Tackling some of the Lean

Six Sigma Deployment Challenges

During this interactive session, speaker faculty members will share their
insights and ideas in an open forum discussion on some of the Lean Six
Sigma deployment challenges. This moderated, open forum discussion will
also provide conference delegates with the opportunity to engage panelists in
dialogue over these issues, as well as share their own thoughts and insights.

2:10

Understanding the Limitations of Lean Six

Sigma: Establishing Inventory Targets and ReOrder Quantities

Basic rules apply to calculating inventory maximum, minimum, and reorder

quantities. This presentation presents the rules and investigates how to
correctly apply Lean Six Sigma principles to inventory controls.
In this session you will learn:
How to calculate Kanban Max, Min, and reorder quantities
Example: how to calculate "normal" inventory parameters
How to reduce your Max, Min, and reorder quantities
What needs to happen before reductions in target inventories occur
How to tell when market or supply chain conditions have changed
How seasonal and unusual events impact the inventory calculation
Example of seasonal inventory and "unusual" events inventory
Typical limitations of Lean to inventory controls
The middle man effect know your supply chain
Data collection: Use data to justify change and to quantify savings
Craig Oppat
Senior Manager
JOHNSON & JOHNSON

3:00

Networking and Refreshment Break

3:30

Balancing the Technical and Human Factors in

Driving Organizational Improvement

Lean Six Sigma presumes standardization and control of processes and their
inputs. From a technical perspective, the "vital xs" within organizations are
relatively easy to improve and control; however, for many of us
improvement and control involve the management of human behaviors.
The human element has the power to make or break improvements, no
matter how elegant the technical solutions. The management of human
factors presents a unique and complex challenge.
This session will discuss:
Examining the controls for the human element in business processes and
services
What we can learn from the domains of organizational effectiveness and
human resources development to manage human behavior and limit variation
Anthony Blandin
Director, Manufacturing
NOVAVAX, INC

4:20

End of Day

Register today! Visit www.iqpc.com/PharmaIQ Call 1-800-882-8684

Main Conference Day 2 Wednesday, March 1, 2006

7:30

Registration

8:15

Chairpersons Welcome and Opening Remarks

8:30

Lean for Speed to Market

Constant struggle in balancing costs and speed to market calls for a new
approach in new product development and transfers to manufacturing.
Lean principles have a proven record of assuring high efficiency in
manufacturing but have an equal potential in the product development
area. This presentation covers a strategic investment decision to deploy
Lean to achieve speed to market. Strategic bet on Lean and flawless
distillation of Voice-of-Customer to vital product characteristics, CTQs, are
the main enablers of a successful product development and launch.
In this session learn about the key elements contributing to a
breakthrough speed to market:
proactive pull-based capacity planning
new product template standardization
5S in key areas impacting new product development and workflow
optimization
Kornelija Zgonc,
Vice President, Functional Excellence
Keynote Speaker
INVITROGEN USA

9:20

PAT Implementation Paths within the

Biopharmaceutical Industry

This session will discuss Process Analytical Technology (PAT) implementation

paths within the biopharmaceutical sector. Bayer Technology Services (BTS)
has expertise in process optimization across various sectors, including the
chemical, pharmaceutical and biotech sectors. The process optimization
tools and methods BTS has developed can be used to implement a
successful PAT strategy, and have been applied with success in these sectors
to improve process quality and increase the capability of the (batch or
continuous) process. Several examples of process optimization, emphasizing
the common factors across these business sectors, will be discussed.
This session will cover:
How PAT contributes to overall process excellence
Implementation of PAT
Risk assessment
Data Management, datamining, and multivariable statistical analysis
Process Control and automation
Peter Ryan, Ph.D., PE,
Engineering Consultant
BAYER TECHNOLOGY SERVICES

10:10

Networking and Refreshment Break

10:40

Taking Lean Six Sigma to the Next Level

Through DFLSS

Of the many improvement methodologies of interest to modern companies,

by far the most popular are Six Sigma and Lean. When people talk about
using Lean Six Sigma, they are typically referring to DMAIC methodology
which is a well-proven Six Sigma methodology however, Design for Lean Six
Sigma (DFLSS) is complementary to the DMAIC methodology but focuses
efforts on designing a product, service or process to achieve Lean Six Sigma
levels of performance before production or implementation. In this session
practical experiences and challenges for the application of specific tools to
improve and sustain your Lean Six Sigma deployment through DFLSS
capabilities will be shown.
In this session learn about:
Applying Lean to Design for Six Sigma (DFSS)
Design for Lean Six Sigma (DFLSS) in Transactional Processes
How DFLSS can improve your performance
Basem Haik
CEO and President
SIX SIGMA PROFESSIONALS, INC

11:30

Applying Lean to a Laboratory Environment

Applying lean principles in a high mix laboratory environment can be difficult.

Understanding where to start can be even more difficult. In this session, learn the
sequence and process used to apply lean tools in a multi-lab environment at BBS.
Topics of discussion will include:
Driving standard work through work station design
Creating operating work teams to drive improvement efforts
Reducing cycle times through labor flexing and workload leveling
Josh Overton
Continuous Improvement Leader
BAXTER BIOPHARMA SOLUTIONS

12:20

Lunch for Speakers and Delegates

1:20

Applying Lean and Six Sigma in Bulk

Biopharmaceutical Production

Lean and Six Sigma are two of the process improvement methodologies
commonly used. Selecting the proper methodology is critical. How do you know
which to use? Which comes first? This session will provide an overview of the
process excellence program at Johnson & Johnson and Centocor. The application
of Lean and Six Sigma in bulk biopharmaceutical production will be covered.
This session will include:
Selecting a methodology - blending Lean and Six Sigma
Using six sigma to improve bioreactor yield case study
Using lean to improve the batch record review process case study
Daniel Zajac
Process Excellence Leader, Master Black Belt
CENTOCOR INC.

2:10

Deploying a Global Process Excellence Organization

Implementation of a Process Excellence Organization to drive Six Sigma, Lean

and Design Excellence methodology is challenging enough at one Biotech
Manufacturing site but how about deployment across a global enterprise
involving multiple manufacturing sites each differing in complexity and
culture. How about deployment across multiple Contract Manufacturing Sites
(Outside Sourcing)? In this session, learn how a Johnson and Johnson Supply
Chain Company tackles creating the right infrastructure and how they
continuously improve the Process Excellence Deployment year after year.
Topics of discussion will include:
Aligning personnel to strategic objectives and metrics.
Deploying Process Excellence out to Contract Manufacturing Global
organizations not under your control
Amilcar Toro, MBB
Director Process Excellence
Global Biologics Supply Chain, CENTOCOR

3:00

Networking and Refreshment Break

3:30

Implementing Lean to Improve the End Product

Before a company can embark on a growth strategy and achieve the success it
desires they first need to take a big step back and look at what it is that needs
adjustment. The big step back often results in a reinvention of the production
model. Its about extending the business and or product in a different direction.
Its not a matter of throwing out the original model/formula, but rather the
creation of an improved one that enables a company to better their end product
and increase overall efficiency. In this session you will learn about Savients
journey of taking the old formula of implementing Lean and developing a
solution to improve the end product with the result of zero deficiencies.
This session will discuss:
Reassessing the old methods
Developing new solutions to drive improvement
Implementing new formulas and increasing quality and efficiency
Carmen Henderson
Senior Director, Manufacturing
SAVIENT PHARMACEUTICAL

4:20

End of Conference

Media Partners

Lean Six Sigma for Pharmaceutical and Biotech Manufacturing Excellence

Philadelphia, PA

Lodging Information

Sponsorship and Exhibit Opportunities

Sponsorships and Exhibits are excellent opportunities for your company to showcase its products and
services to high-level, targeted decision makers attending the Lean Six Sigma for Pharmaceutical and
Biotech Manufacturing Excellence conference. PharmaIQ and its Lean Six Sigma for Pharmaceutical
and Biotech Manufacturing Excellence conference helps companies like yours achieve sales, marketing
and branding objectives by setting aside a limited number of event sponsorships and exhibit spaces - all of
which are custom-tailored to help your company create a platform to maximize its exposure at the event.
For more information on Sponsoring or Exhibiting at the Lean Six Sigma for Pharmaceutical and
Biotech Manufacturing Excellence conference, please contact Shannon Forrester at
1-212-885-2719 or via email at sponsorship@iqpc.com.

Unmatched Networking Opportunities:

Lean Six Sigma for Pharmaceutical & Biotech Manufacturing Excellence will run concurrently
with our 3rd Annual Technology Transfer Summit for Pharmaceutical & Biotech Industries
conference. This gives participants a unique and unparalleled opportunity to custom design their own
networking experience and meet a wide array of highly regarded professionals in the pharmaceutical
& biotech industry. Attendees can also benefit from team discounts for both conferences. For
more information, please contact IQPC Customer Service at 1-800-882-8684.

Sessions for the Conference

and Workshops will be held at:

Doubletree Hotel
Philadelphia
237 Broad Street
Philadelphia, PA 19107
Phone: 215-893-1600
Fax: 215-893-1664
To secure reduced rates, please
contact the hotel at least four
weeks prior to the conference and
be sure to mention the conference
name. Note: Contact hotel for
direction and transportation
suggestions.

REGISTER BY PHONE, FAX, E-MAIL OR WEB SITE

Details for making payment via EFT or wire transfer:
JPMorgan Chase
Penton Learning Systems LLC dba IQPC: 957-097239
ABA/Routing #: 021000021
Reference: Please include the name of the attendee(s) and the event number:
2403.01

Web:

www.IQPC.com/pharmaIQ

Phone:

1-800-882-8684 or 973-256-0211

Fax:

973-256-0205

Mail:

International Quality & Productivity Center

555 Route 1 South, Iselin, NJ 08830

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FDA and government employees are eligible for other savings, please contact
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Note: One form of discount is available per registrant.

Payment Policy: Payment is due in full at the time of registration and includes
lunches, refreshment and detailed conference materials. Your registration will not be
confirmed until payment is received and may be subject to cancellation.
IQPC Cancellation, Postponement and Substitution Policy: You may substitute
delegates at any time. IQPC does not provide refunds for cancellations. For
cancellations received in writing more than seven (7) days prior to the conference you
will receive a 100% credit to be used at another IQPC conference for up to one year
from the date of issuance. For cancellations received seven (7) days or less prior to an
event (including day 7), no credit will be issued. In the event that IQPC cancels an
event, delegate payments at the date of cancellation will be credited to a future IQPC
event. This credit will be available for up to one year from the date of issuance. In the
event that IQPC postpones an event, delegate payments at the postponement date
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rescheduled event, the delegate will receive a 100% credit representing payments
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IQPC is not responsible for any loss or damage as a result of a substitution, alteration
or cancellation/postponement of an event. IQPC shall assume no liability whatsoever
in the event this conference is cancelled, rescheduled or postponed due to a fortuitous
event, Act of God, unforeseen occurrence or any other event that renders
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extreme weather or other emergency. Please note that speakers and topics were
confirmed at the time of publishing, however, circumstances beyond the control of the
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Please note that speakers and topics were confirmed at the time of publishing,
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Register today! Visit www.iqpc.com/PharmaIQ Call 1-800-882-8684

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Register today! Visit www.iqpc.com/PharmaIQ Call 1-800-882-8684

Lean Six Sigma

for Pharmaceutical
and Biotech
Manufacturing
Excellence

Increasing Productivity, Efficiency and

Customer Satisfaction with Lean and Six
Sigma Techniques

A Case Study on How to Successfully Deploy Lean

Featuring Best Practice

Case Studies from these
Leading Organizations:
INVITROGEN, USA
JOHNSON & JOHNSON
SCHERING-PLOUGH
CORPORATION
AMGEN INC.
SAVIENT
PHARMACEUTICAL
TAP PHARMACEUTICAL
PRODUCTS INC.
NOVAVAX, INC
BAXTER BIOPHARMA
SOLUTIONS
CENTOCOR
PRTM MANAGEMENT
CONSULTANTS
BAYER TECHNOLOGY
SERVICES

Dont Miss the Highly

Interactive Workshops By:
PHARMATECH
ASSOCIATES
OMNEX, INC
SIX SIGMA
PROFESSIONALS, INC.
The author of SIX SIGMA
SIMPLIFIED, LEAN
SIMPLIFIED

How to Reduce Rework & Eliminate Deviations

While Continuing to Maintain Compliance and
Quality

February 27-March 1, 2006

Doubletree Hotel Philadelphia

Philadelphia, PA

Tools to Improve and Sustain

Your Lean Six Sigma
Deployment Through DFLSS
Capabilities

Reducing Cycle Times Through Labor Flexing and

Workload Leveling

Strategies to be Discussed Include:

Successfully Applying Lean

Six Sigma Principles to
Inventory Controls

Media Partners:

Register today! Visit www.iqpc.com/PharmaIQ Call 1-800-882-8684