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NEW FOR 2012:
                                              is pleased to announce the
                                                                                                       Breakout Sessions
                                                                                                    Personalize Your Agenda
  13th Annual

  Lean Six Sigma
  for Pharmaceutical, Biotech,
  and Medical Device Excellence
       Advancing Continuous Improvement                                            Learn case studies & best practices
                                                                                   from these leading industry experts:
       and Innovation within Your Organization                                           Hillary M. Wilson           Michael McSweeney
                                                                                         Business Operations         Senior Operational
       February 21-23, 2012 | Atlanta, GA                                                Lead, Pradaxa Marketing
                                                                                         Boehringer Ingelheim
                                                                                                                     Excellence – LSS
                                                                                                                     Master Black Belt
                                                                                         Pharmaceuticals, Inc.       GlaxoSmithKline
       www.LSSPharma.com
                                                                                         Terence Barnhart            Lyndi Cole
       TOP REASONS TO ATTEND:                                                            Senior Director             Operational
       Create your own personalized conference agenda by selecting                       Pfizer Worldwide R&D        Excellence Expert
                                                                                                                     GlaxoSmithKline
       among our featured plenary & breakout session topics:
           •	 Culture &                               •	 Optimized LSS                                               Brian Eden
              Management Buy-in                          Project Portfolio               Paul Nelson                 Senior Director and
           •	 Lean & Six Sigma Trends                 •	 Supplier Integration            Supply Chain Senior         Global Head, Operational
                                                                                         Director & Lean             Excellence
           •	 Research & Development                  •	 Sales & Marketing               Sigma Leader                Mylan
              (R&D)                                   •	 Lean A3 Problem Solving         Shire Pharmaceuticals       Pharmaceuticals
           •	 Lean Innovation                            Method                          Inc.
           •	 Regulatory Compliance                   •	 Manufacturing                                               Winston Brown
           •	 Capital Improvements                    •	 Silos                           Charles Aubrey              Director, Global Quality
                                                                                         Vice President of Quality   Compliance
           •	 Strategic Supplier                      •	 Benchtop Equipment                                          Baxter HealthCare
              Partnerships                               Selection                       and Lean Six Sigma
                                                                                         Anderson                    Corporation
           •	 Employee Engagement                     •	 Regulated QC                    Pharmaceutical
           •	 Mature Programs/                           Laboratory                      Packaging                   William Favier
              Projects                                •	 Lean Laboratory                                             Director,
           •	 Mergers/Acquisitions                    •	 Packaging                                                   Lean Sigma Training
                                                                                         Deepa Kumar
                                                                                                                     Bristol-Myers Squibb
           •	 Knowledge & Change                      •	 TPS Pillar of Jidoka            Operational
                                                                                                                     Co.
              Management                                                                 Excellence Expert
                                                                                         GlaxoSmithKline
           Register by 12/16/11 to receive the lowest available price!                                               Nick Ruhmann
                                                                                                                     Continuous Improvement
                                        See page 8                                       Diane Francisco             Leader, Master Black Belt
                                                                                         Director of Process         BD Medical -
                                                                                         Excellence, Global          Diabetes Care
                                                                                         Commercial Organization
  Follow                                                                                 Covance
  our expert                                                                                                         Kelly Kujan
                                                                                                                     Vice President of
  speakers on:                                                                                                       Continuous Improvement
                                                                                         David Haigh, Sr.
Sponsor:                                Media Partners:                                  Process Excellence          Fenwal Inc.
                                                                                         Manager
                                                                                         Johnson & Johnson Inc.      AND MANY MORE. . . .
                                                                                         (Canada)


    1-800-882-8684 | info@iqpc.com | www.LSSPharma.com
13th Annual

Lean Six Sigma                                                                                             WHO WILL YOU
                                                                                                           NETWORK WITH?
                                                                                                           Champions, Master Black
for Pharmaceutical, Biotech,                                                                               Belts, Black, Green, Belts
                                                                                                           Executive/ Senior Vice
and Medical Device Excellence                                                                              Presidents,Vice Presidents,
                                                                                                           Directors, Project
                                                                                                           Coordinator, Managers,
                                                                                                           Heads and leaders of:
    Dear Colleague,                                                                                          •	   Lean Six Sigma
                                                                                                             •	   Process Excellence
    IQPC is proud to present the 13th Lean Six Sigma for Pharmaceutical, Biotech and Medical                 •	   Operational Excellence
    Device Excellence	Conference.		For	the	first	time	on	the	East	Coast	this	event	will	feature	             •	   Business Excellence
    breakout sessions designed to provide additional content for delegates to choose from.                   •	   Continuous
                                                                                                                  Improvement
                                                                                                             •	   Knowledge &
    Personalize your conference agenda and tackle your biggest hurdles and areas of interest.                     Change Management
    You will hear over 28+ in-depth case studies and workshops bringing you innovative solutions             •	   Strategy Management
    addressing top industry concerns including:                                                              •	   QA/QC
        •	 Analyzing the latest and upcoming trends in this industry                                         •	   Research &
        •	 Deploying LSS in a regulated business                                                                  Development
        •	 Utilizing lean six sigma throughout your entire organization -                                    •	   Clinical Trials
              beyond manufacturing                                                                           •	   Sales & Marketing
                                                                                                             •	   Manufacturing
        •	 Selecting and resourcing the optimized LSS project portfolio                                      •	   Engineering
        •	 Building vendor partnerships & becoming strategic with your suppliers                             •	   Innovation
        •	 Achieving sustainability and success through knowledge & change management                        •	   Validation
        •	 Fostering a culture of continuous improvement and understanding the value of                      •	   Regulatory Compliance
              employee engagement                                                                            •	   Information Technology
        •	 Opportunities in the regulated QC laboratory                                                      •	   Supply Chain
        •	 Applying the Lean A3 problem solving method                                                       •	   Logistics
                                                                                                             •	   Supplier Quality
        •	 Addressing the next steps for mature six sigma & lean projects/programs
                                                                                                             •	   Accounting/Finance
        •	 Implementing lean innovation: a	framework	to	improve	efficiency	&	effectiveness	of	               •	   Packaging
              the innovation process                                                                         •	   Laboratory
                                                                                                           See who
    Additionally, this event offers interactive networking opportunities and sessions. This is your
                                                                                                           attended previous
    opportunity	to	share	specific	challenges	affecting	your	organization,	exchange	contact	information	    events here.
    and learn from knowledgeable leaders in this space.

    Be sure to register yourself and a team of key people for
    this important event today. Don’t miss this chance to                                                                  Join our
                                                                                   e
    benchmark against developing and proven strategies.             P.S. Attend th                                    global online
                                                                         MUST SEE                                       community
    Sincerely,                                                           pre-conference                             and download
                                                                                              d to
                                                                         workshops designe                           exciting new
                                                                         address challen  ges and                   webinars and
                                                                                             diate
                                                                         come up with imme                     podcasts developed
    Claudia Rubino                                                        actionable so lutions!                by industry leaders
    Program Director                                                      See page 3.                                    for IQPC.
    Six Sigma & Process Excellence IQ, division of IQPC
    Claudia.Rubino@IQPC.com



SPONSORSHIP & EXHIBITION OPPORTUNITIES                                                                     About the organizer:
                                                                                                           Six Sigma IQ, a division of
Event sponsorship is an excellent opportunity for your company to showcase its products and                IQPC, provides useful
services to high-level, targeted decision makers attending the 13th Lean Six Sigma for                     training courses, conference
Pharmaceutical, Biotech & Medical Device Excellence Conference. IQPC and Six Sigma &                       and expositions for
Process Excellence IQ help companies like yours achieve important sales, marketing, and branding           pharmaceutical executives to
objectives by setting aside a limited number of event sponsorships – all of which are tailored to assist   network and learn
your organization in creating a platform to maximize its exposure at the event. For more information       the latest pharma business
                                                                                                           development and
on sponsoring at this or upcoming events, please contact Kimberly Sun at (212) 885-2662 or                 trends occurring in
 Kimberly.Sun@iqpc.com.                                                                                    organizations today.

2                1-800-882-8684 | info@iqpc.com | www.LSSPharma.com
Pre – Conference Workshops
Tuesday, February 21, 2012
              Our series of workshops have been designed to translate winning strategies from leading experts and develop them
                   into	tangible	benefits	you	can	take	away	and	implement	within	your	own	company’s	procedures.		Join	the	
              13th LSS for Pharmaceutical, Biotech, Medical Device Excellence resourceful workshops to enhance your expertise.



A             8:00am – 10:30am                       7:30am Registration for Workshop A (Refreshments will be served)
              SELECT AND RESOURCE THE OPTIMIZED LSS PROJECT PORTFOLIO
 Projects for Process Improvement are often selected individually, on the merit of each        	   •	 How to aggregate resources required for the portfolio
 project. While this works on the project level, it does not lead to a successful program of   	   •	 How to select the portfolio that maximizes attainment of
 Process Improvement within the company. The portfolio of projects needs to be viewed                 company goals
 as a whole, and individual projects added to it in a way that links with company strategic    	   •	 How to ensure that the resources are in place to carry out the
 goals. Also, the resources may not be in place and available to successfully complete                portfolio of projects
 all projects, or there may be overlap between projects that create problems. For the
                                                                                               How you will benefit:
 Process Improvement program to be successful, project selection must be done as part of
                                                                                               	 •	 Maximize the odds that your projects achieve their goals
 Portfolio Management. Developing the optimal portfolio is the goal of this workshop:
                                                                                               	 •	 Reduce frustration among overworked team resources
 What will be covered:                                                                         	 •	 Be able to see the big picture of what your Process Improvement
 	 •	 How to evaluate single projects                                                               program is doing
 	 •	 How to link individual project goals to company goals                                    	 •	 Maximize the value of the portfolio of projects to the company
 	 •	 How to identify inter-dependencies between projects
 	 •	 How to detail the resource needs of a project                                            Your Workshop Leader:
                                                                                               Dr. Mark Gershon, SSMBB, President, World Class Training Institute




B             11:00pm -1:30pm
              LEAN A3 PROBLEM SOLVING METHOD
                                                     10:45am Registration for Workshop B (Boxed Lunches will be Served)


 Much more than just a tool, A3 Problem Solving is a simple method to systematically           	   •	 An intuitive and easy way to learn and remember
 help	define	and	solve	problems.		This	workshop	will	explore	a	way	of	thinking	that	causes	
                                                                                               How you will benefit:
 entire teams of people to sharply focus their minds on the foundational Lean ways
                                                                                               	 •	 Improve	your	ability	to	define	and	solve	problems
 of	seeing	process	flows	and	wastes,	constantly	redirecting	their	attention	back	to	the	
                                                                                               	 •	 Teach managers how to better coach, mentor, and lead
 foundational lean teachings:
                                                                                               	 •	 The A3 method offers a long-missing standardized approach to solving
 What will be covered:                                                                         	 	 problems	identified	in	higher-level	value	stream	maps
 	 •	 Simple and consistent way to achieve and document root cause analysis
                                                                                               Your Workshop Leaders:
 	 •	 Create the target condition
                                                                                               Terence Barnhart, Senior Director, Pfizer Worldwide R&D




C             2:00pm – 4:00pm                        1:45pm Registration for Workshop C (Refreshments will be served)
              THE FALLEN TEMPLE – HOW THE TPS PILLAR OF JIDOKA IS MORE THAN JUST AUTONOMATION
 This discussion will center on research completed by notable author and MIT lecturer          How you will benefit:
 Steven Spear and how it was incorporated by Toyota into their supplier training in regard     	 •	 Gain a better understanding of the Jidoka Pillar, and how ignoring it causes
 to the lack of understanding of the Jidoka Pillar by western companies. Analyze how a         stagnation in the ability to be “Just in Time”
 focus on the visible aspects of Toyota have created a gap in the understanding of Lean and    	 •	 Understand	the	capabilities	we	as	leaders	should	be	propagating	in	all	employees
 resulted in the stagnation of many companies Lean journey.                                    	 •	 Actual Gemba Kaizen - apply the principles on our host location before leaving!
 What will be covered:                                                                         Your Workshop Leader:
 	 •	 Error prone vs. high performance systems                                                 Nick Ruhmann, Continuous Improvement Leader, Master Black Belt,
 	 •	 Capabilities of the operational outstanding                                              BD Medical – Diabetes Care
 	 •	 True north (ideal state)
 	 •	 The	FOUR	levels	of	process	design




D             4:30pm – 6:30pm                        4:15pm Registration for Workshop D
              LEAN INNOVATION: A FRAMEWORK TO IMPROVE EFFICIENCY & EFFECTIVENESS OF THE INNOVATION PROCESS
 Most Lean implementations have been used to reduce waste in operations. Deploying             What will be covered:
 Lean has led to cost savings and excess capacity in equipment and human resources.            	 •	 Learn the innovation framework consisting of fundamental business strategy
 Leadership	and	stakeholders	expect	financial	returns.		Utilizing	Lean	aggressively	for	       	 •	 Incentives for inspiration, rules of creativity and types of thinking
 reducing waste has also resulted in ignorance of the need for business growth requiring       	 •	 Analysis of the phases of an innovation methodology
 innovation.	Hence	Lean	without	innovation	would	result	in	profit	in	a	shrinking	business.	
                                                                                               How you will benefit:
 This scenario does not appear a viable solution for businesses in the long. Operational
                                                                                               	 •	 Utilize	TEDOC	methodology	for	innovative	deployment	of	lean	for	better	
 performance accounts for about 10% of the corporate performance. In order to
                                                                                                    outcomes and for developing new products or solutions for revenue growth
 maximize	benefits	of	Lean	Six	Sigma,	corporations	must	focus	on	business	development	
                                                                                               	 •	 Take away a better understanding of Lean Six Sigma Assessment Tool
 by introducing new products or services. Lean Innovation is a framework that improves
                                                                                               	 •	 Discover a simple yet powerful creativity process
 efficiency	and	effectiveness	of	the	innovation	process	based	on	best	practices	of	great	
                                                                                               	 •	 Make use of lean innovation methodology and innovative ideas for current
 innovators. Lean Innovation framework reduces waste in the innovation process
                                                                                                    project(s) at work in your organization
 for accelerating innovation and increasing return on investment in innovation. This
 way additional capacity is utilized for realizing business growth instead of downsizing       Your Workshop Leader:
 businesses. This workshop will assess their Lean Six Sigma initiatives and corporate          Praveen Gupta, President, Accelper Consulting
 performance, use ideation process in lean deployment, and practice creativity:




1-800-882-8684 | info@iqpc.com | www.LSSPharma.com                                                                                                                                     3
MAIN CONFERENCE DAY 1
Wednesday, February 22, 2012
8:00    REGISTRATION AND COFFEE

8:50    CHAIRPERSON’S WELCOME AND OPENING REMARKS

                                         TRENDS & DEVELOPMENTS WITHIN LEAN/SIX SIGMA WORLD

9:00    KEYNOTE/PANEL DISCUSSION: WHAT LIES AHEAD: DISCUSSING TOP TRENDS AND DEVELOPMENTS
        The	pharmaceutical,	biotech	&	medical	device	industries	have	seen	the	initial	benefits	of	implementing	six	sigma	&	lean	processes	and	techniques	into	their	
        everyday	operations.		With	many	of	these	programs	finally	seeing	some	initial	benefits	and	drawbacks	and	as	the	stories	of	successes	and	failures	continue	
        to be shared, many business improvement professionals are wondering which direction the trends and development within this space heading. This panel
        discussion will focus on:
        •	 What is new in Lean Six Sigma
        •	 What new trends and old trends continue
        •	 Have any activities failed and gone by the wayside
        •	 How to expand the applications outside of production (labs, R&D, etc)
        •	 Practices or approaches being adopted from other industries
        •	 Tools or programs that are standing the test of time and really sustaining excellence
        •	 How to streamline and control the phases of improvement projects
        Panelists:
        Dr. Mark Gershon, SSMBB, President, World Class Training Institute
        Charles Aubrey,Vice President, Anderson Pharmaceutical Packaging
9:45    CASE STUDY: “THE NEED FOR SPEED”
        In today’s fast-paced environment many of us are struggling with how to use the Lean and Six Sigma tools and approaches we grew up with (which are now
        50-60 years old) to meet the speed demanded by our businesses. We’ll explore why things are going faster, some orthodoxies that need to be reexamined
        in	light	of	the	changing	environment,	give	specific	examples	of	how	some	basic	Lean	Sigma	tools	and	approaches	can	be	tweaked	and	adjusted	to	speed	up	
        the process and discuss how the “democratization of learning” can be leveraged to make organizations more responsive. Here you will:
        •	 Understand		todays	business	and	its	fast	paced	environment
        •	 Learn a step by step approach to improving your current operations
        •	 Determine the best tools and approaches to increase the speed of your operation
        Speaker:
        William Favier, Director, Lean Sigma Training, Bristol-Myers Squibb Co.
        John	Ghidiu,	Certified	Six	Sigma	Black	Belt	(ASQ),	Certified	Performance	Technologist	(ISPI),		Certified	Professional	in	Learning	and	Performance	
        (ASTD)
10:30   MORNING NETWORKING AND REFRESHMENT – CARD EXCHANGE

                      PACKAGING/MANUFACTURING                                                                SALES & MARKETING
11:15    CASE STUDY: APPLYING INNOVATION TO                                             CASE STUDY: DEPLOYING LEAN SIX SIGMA IN A SALES
         PHARMACEUTICAL PACKAGING:                                                      AND MARKETING ORGANIZATION
         BETTER PATIENT OUTCOMES                                                        Implementation of Lean Six Sigma (LSS) in contract service companies
         Innovation is the key to success for any business. Determining the best way    would not be considered to be novel or new these days. Service
         to apply this concept within your operations and procedures will be an         companies have embraced this structured approach for continuous
         essential and crucial step to continuous improvement. Join us in analyzing     improvement of their key operational processes. They have shown success
         Anderson Pharmaceutical Packaging’s development, implementation and            in reducing cycle time, improving quality and creating value for their
         assessment of their innovation initiative within their packaging department,   customers and businesses. With all of this success, one might assume that
         and	analyzing	the	keys	benefits	and	lessons	learned	throughout	their	          LSS would be practiced in all areas of the organization. This assumption
         journey. This case study will:                                                 however would be false. Sales and Marketing were areas that LSS was
         •	 Review the various innovation methods: Design for Six Sigma,                believed to not be applicable. It is only recently that deployment of LSS in
             Blue Ocean and TRIZ                                                        Sales and Marketing groups has been seen as a value add. Key points that
         •	 Discuss the process to convert innovations to patents                       will be discussed include:
         •	 Demonstrate how patented products can be commercialized                     •	 Get your foot in the door: Put process excellence and improvement in
         •	 Show how the develop investment and commercialized                              front of mind for management in all strategy
         	 innovations	realize	significant	payback                                      •	 Develop a deployment roadmap or plan that meets the needs of the
         •	 Prove how the innovations provide better health outcomes for patients           Sales and Marketing groups, while taking in to consideration the group
         Speaker:                                                                           cultures
         Charles Aubrey,Vice President, Anderson Pharmaceutical Packaging               •	 Achieve organizational alignment between leadership targets and
                                                                                            improvement goals for maximum project impact
                                                                                        •	 Develop	a	flexible,	yet	standard,	framework	for	scoping,	prioritizing	and	
                                                                                            executing improvement projects
                                                                                        Speaker:
                                                                                        Diane Francisco, Director of Process
                                                                                        Excellence, Global Commercial Organization, Covance


12:00   CASE STUDY: MEASUREMENT SYSTEM ANALYSIS (MSA)                                   CASE STUDY: BEST PRACTICE – ASSESSING OPERATIONAL
        FOR BENCHTOP EQUIPMENT SELECTION                                                IMPROVEMENT OPPORTUNITIES FOR PHARMACEUTICAL
        This is a case study based on a project that allowed the GSK                    SALES & MARKETING TEAMS
        Biopharmaceutical manufacturing group to choose benchtop equipment              This presentation will review methods for assessing productivity
        (such as those used to assay in-process test samples) to better suit the        improvement opportunities in sales and marketing. The presentation
        needs warranted by the drug substance manufacturing process. In the past        focuses	on	designing	the	assessment	approach,	assessing	benefit	and	effort,	
        such decisions were not always made using a statistically driven approach.      and gaining key stakeholder alignment. Attendees will receive a long list of
        You will learn to:                                                              potential places to look within their organizations to identify.


4               1-800-882-8684 | info@iqpc.com | www.LSSPharma.com
MAIN CONFERENCE DAY 1
Wednesday, February 22, 2012
         •	 Use	of	the	DMAIC	methodology	with	a		cross	functional	team	to	               •	 Gotta take 10% out of your budget and still do all the same
            understand process / customer requirements for the assay in question             work: Address this situation at your company
         •	 Design appropriate Measurement Systems Analysis experiments                  •	 Marketing stakeholder management in an environment that is
            involving equipment/instruments, analysts, number or samples,                    resistant to change
            replicates, etc. to obtain enough data to be studied                         •	 Pharma marketing agencies – setting new expectations of
         •	 Employ statistics to understand variability of each piece of                     productivity
            equipment for the manufacturing process                                      Speaker:
         •	 Implement a weighted matrix approach using the statistical data              Hillary M. Wilson, Business Operations Lead, Pradaxa Marketing,
            to make decisions on equipment selection                                     Boehringer Ingelheim Pharmaceuticals, Inc.
         Speaker:
         Deepa Kumar, Operational Excellence Expert, GlaxoSmithKline
         Lyndi Cole, Operational Excellence Expert, GlaxoSmithKline
12:45   NETWORKING	LUNCHEON
1:45    CASE STUDY: ENSURE VALIDATION THROUGHOUT YOUR PRODUCT LIFECYCLE
        With an ultimate goal of eliminating waste, Kaizen focuses on improving standardized activities and processes. When used appropriately, this method can
        be utilized to standardize an organization’s operations leading to improved quality and greater productivity. Join us in highlighting the steps to a successful
        Kaizen implementation. You will learn to:
        •	 Implement continuous process improvement in manufacturing, engineering, supporting business processes, supply chain and management
        •	 Clarify the steps required to standardize an operation
        •	 Measure a standardized operation and standardizing the new, improved operations
        •	 Highlight innovative approaches to meet requirements and increase productivity
        Speaker:
        Winston Brown, Director, Global Quality Compliance, Baxter HealthCare Corporation
2:30    CASE STUDY: OPPORTUNITIES FOR LEAN SIX SIGMA IN                                 CASE STUDY: ACHIEVE RESULTS THROUGH BUSINESS
        THE REGULATED QC LABORATORY                                                     PROCESSES & CORPORATE FUNCTIONS
        Once the primary domain of manufacturing operations, Lean Six Sigma             Integrating Lean Six Sigma throughout an organization’s core business
        approaches are now penetrating analytical quality testing laboratories and      operations	to	achieve	early	benefits	and	full	self-sustainability	necessitates	
        Quality Assurance (QA) organizations. As economic imperatives coupled           a strong focus on core business processes and corporate functions. In this
        with cultural shifts and technological advancements prevail over the            session, you will learn real examples on how to use Lean and Six Sigma to
        historical aversion to change in these regulated environments, more Lean        create agile business processes and to ensure your organization’s survival is
        Six Sigma projects are moving from the perimeter of laboratory operations       this through economic and competitive environment. This case study will
        deeper	into	QC	workflows.		This	case	study	will:                                teach you to:
        •	 Ensure data is captured completely and correctly to support                  •	 Assess both internal and external business processes
            regulatory compliance                                                       •	 Analyze successful practices to streamline business processes &
        •	 Use	integrated	laboratory	informatics	systems	for	traceability	of	               corporate functions
            batch record information, laboratory assets, analytical testing             •	 Address	common	difficulties	and	drawbacks
            data, reports, etc.                                                         •	 Develop a step by step approach towards effecting change
        •	 Highlight	the	incorporation	of	procedure-based	workflows	into	               •	 Explore	common	difficulties	and	drawbacks
            laboratory execution systems (LES)                                          Speaker:
        Speaker:                                                                        Terence Barnhart, Senior Director, Pfizer Worldwide R&D
        Cozette Cuppett, Senior Informatics Marketing
        Manager, Americas, Waters Corporation

3:15    AFTERNOON NETWORKING AND REFRESHMENT BREAK
4:00    BUSTING THROUGH THE SILOS: CONNECTING THE FULL VALUE STREAM
        Creating a meaningful and sustainable culture of excellence requires connecting all of the “dots” to drive superior value for the customer. Too often,
        continuous	improvement	programs	experience	a	drop	off	in	benefit	or	“hit	the	wall”	once	a	manufacturing	site	or	distribution	center	has	optimized	its	core	
        processes. Driving to the next level of transformation requires that all of the supporting transactional areas adhere to the core principles of a “LEAN
        Enterprise”, it simply requires practitioners to translate the work to a new environment. Join us for this interactive conversation designed to help with the
        translation to create outstanding results.
        •	 How can your organization move from a vertical to horizontal view
        •	 How you can approach the deployment of LEAN in your transactional areas
        •	 Understand	what	will	be	required	from	your	Leadership	to	support	the	change
        •	 Gain 3-4 practical ideas that you can immediately apply to your situation
        William Owad, SVP, Operational Excellence, Cardinal Health
4:45    BUILD VENDOR PARTNERSHIPS AND BECOME STRATEGIC WITH YOUR SUPPLIERS
        Developing a door-to-door (D2D) product value stream requires extending the value stream to include your vendors. Do you know your vendor’s process
        capabilities and value streams? The answer to both of these questions will have a direct impact on your current vendor partnership and will become the
        base on which to begin building a strategic approach with your suppliers. This session will focus on:
        •	 Developing Value Stream Maps (VSM) for each BOM component (start with “runners”)
        •	 Future	State	VSM	identifies	continuous	improvements	projects
        •	 Both you and vendor focused on same projects
        •	 Develop visual controls and metrics
        •	 Quality assurance reduced testing project
        •	 Risks	identified	and	assessed	(single	source,	specialty	items,	long	lead	times,	and	etc)	
        •	 Replenishment strategies (vendor managed inventory, consignment stock, supplier hubs, kanbans)
        Speaker:
        Michael McSweeney, Senior Operational Excellence – LSS Master Black Belt, GlaxoSmithKline
5:30    Please join us for opportunity to exchange contact information with all delegates, speakers and sponsors.
                                                                                                                                                     Expand
        Take advantage of this opportunity to expand your network and gain quality contacts within you field.                                      your Lean
        P.S. Please bring your business cards!!!                                                                                                   Six Sigma
5:50    END OF MAIN CONFERENCE DAY 1
                                                                                                                                                    network.


1-800-882-8684 | info@iqpc.com | www.LSSPharma.com                                                                                                                        5
MAIN CONFERENCE DAY 2
Thursday, February 23, 2012

7:55    REGISTRATION AND COFFEE

8:25    CHAIRPERSON’S RECAP OF MAIN CONFERENCE DAY 1

                                                          CULTURE/MANAGEMENT BUY-IN

9:00    KEYNOTE/PANEL DISCUSSION: ADDRESS CULTURE & MANAGEMENT BUY-IN
        This session has been constructed to help increase dialog and knowledge transfer between leading industry experts and provide key
        experiences addressing culture and management buy-in. To facilitate this learning, the session leader will begin with a few suggestions of
        major challenges related to culture and open it up to the audience. This panel/learning format opens the lines of communication and is
        designed	for	speakers,	delegates	and	service	providers	alike.		The	goal	of	this	session	is	to	share	specific	cultural	challenges	and	ideas	and	
        learn from one another.
        •	 Determine the keys to establishing effective culture changes
        •	 Market stakeholder management in an environment that is resistant to change
        Panelists:
        Brian Eden, Senior Director and Global Head, Operational Excellence, Mylan Pharmaceuticals
        Kelly Kujan,VP of Continuous Improvement, Fenwal Inc.
        Hillary M. Wilson, Business Operations Lead, Pradaxa Marketing, Boehringer Ingelheim Pharmaceuticals, Inc.

9:45    CASE STUDY: THE VALUE OF EMPLOYEE ENGAGEMENT – HOW TO TURN 600 PEOPLE INTO 4000+
        IMPROVEMENTS
        See how a Becton Dickinson plant has turned all 600 of its employees into problems solvers and waste eliminators, and continued to
        increase	both	the	quality	and	quantity	of	the	ideas	submitted	with	minimal	investment.	Understand	the	important	difference	between	a	
        “suggestion program” and a “kaizen” program, both in the impact to the company, and to individuals thinking habits. This case study will
        teach you to:
        •	 Handle a large volume of kaizen ideas through gradual use of manual to IT solutions
        •	 How to keep the program increasing quality and quantity every year
        •	 How a rewards system can help to motivate “exceptional” kaizens and identify stand out employees
        •	 Think of kaizens as problem solving practice for every employee
        •	 To	use	kaizen’s	as	a	coaching	/	mentoring	opportunity	to	increase	management	/	shop	floor	cooperation.
        Speaker:
        Nick Ruhmann, Continuous Improvement Leader, Master Black Belt, BD Medical - Diabetes Care
        Gert Coetzer, Lean Coordinator, BD Medical - Diabetes Care

10:30   MORNING NETWORKING AND REFRESHMENT BREAK - DO YOU NEED TO… (VENDOR SOLUTIONS)

                                                               A HOLISTIC VIEW

11:15   CASE STUDY: THE STRATEGY OF OPERATIONAL EXCELLENCE
        Join us in exploring a case study focusing on strategic questions. Every organization must be able to answer key questions in order to
        ensure effective operational excellence programs and procedures. This case study will focus on:
        •	 Does your Lean/Six Sigma program support the corporate mission?
        •	 What are your bench marks?
        •	 How do you know your Lean/Six Sigma program is working? Is it sustainable?
        •	 What	gaps	need	to	be	filled	–	Short	term?	Long	term?
        Speaker:
        Paul Nelson, Operational Excellence Leader,
        Shire Pharmaceuticals Inc.

12:00   CASE STUDY: MANAGING CHANGE IN LEAN SIX SIGMA DEPLOYMENTS IN HIGHLY
        REGULATED ENVIRONMENTS
        Continuous improvement deployments can be fragile. One key to their successful uptake is cultivation of strong sponsorship and
        proper management of natural resistance to the changes the improvement work will bring. Resistance to change is natural in all areas of
        continuous	improvement	application.		Highly	regulated	industries	such	as	food	and	pharmaceuticals	have	specific	considerations	in	this	
        regard. This session will focus on:
        •	 Methods to assess, cultivate and sustain sponsorship for continuous improvement work
        •	 Lessons learned from deployment work in food and pharmaceutical continuous improvement start ups
        •	 Questions, answers and sharing from the larger group on what works, what doesn’t work, and tips and tricks to manage complex change
           landscapes
        Speaker:
        Brian Eden, Senior Director and Global Head, Operational Excellence, Mylan Pharmaceuticals

12:45   NETWORKING LUNCHEON


6              1-800-882-8684 | info@iqpc.com | www.LSSPharma.com
MAIN CONFERENCE DAY 2
Thursday, February 23, 2012

                                            POST IMPLEMENTATION: ASSESS THE RESULTS

1:45     PANEL DISCUSSION: WHAT’S NEXT? TAKE THE NEXT STEP WITH PROJECT & PROGRAMS APPROACHING OR
         ALREADY IN A MATURE STATE
         As many organization’s programs/projects for business Performance Excellence move into a mature state, many fail to deliver on the
         dream of establishing a culture of continuous improvement. When the obvious waste and the initial opportunities have been tackled,
         where do you look next? When the enthusiasm and interest of the executive team is waning, how can you revive your project/program
         and renew interest? This session will focus on:
         •	 Step by step overview of the entire continuous improvement process
         •	 Reviving your team and gaining executive team support
         •	 Continuous improvement processes across departments
         Speaker:
         Nick Ruhmann, Continuous Improvement Leader, Master Black Belt, BD Medical - Diabetes Care
         Brian Eden, Senior Director and Global Head, Operational Excellence, Mylan Pharmaceuticals

2:30     CASE STUDY: LARGE SCALE MERGER: DETERMINE THE NEXT STEPS
         Lean Six Sigma can offer a number of techniques that can quickly yield operational insights at all stages of the merger & acquisition
         process, from due diligence through integration and beyond. Management needs to understand and view the application of six sigma as
         a catalyst to the M&A process, and not as an added work & cost. This case study will highlight the strategic approach taken by Covance
         when	facing	the	daunting	task	of	merging	two	organizations	into	one	streamlined	efficient	operating	machine.			You	will	learn	to:
         •	 Assess current processes, strategies and goals for both organizations
         •	 Accelerate through the use of tools integrated through this strategic partnership
         •	 Understand	the	pitfalls	and	complication	resulting	from	a	large	scale	merger
         •	 Align both organization’s goals and processes
         Speaker:
         Kelly Kujan,VP of Continuous Improvement, Fenwal Inc.

3:15     AFTERNOON NETWORKING AND REFRESHMENT BREAK

                                                  CHANGE/KNOWLEDGE MANAGEMENT

4:00     CASE STUDY: CHANGE MANAGEMENT: INFLUENCING CUSTOMER-FACING AND
         CUSTOMER-CONTRIBUTING PROCESSES
         This	presentation	will	cover	a	series	of	case	studies,	describing	recent	successes	at	Johnson	&	Johnson	affiliates	to	improve	their	
         customer-facing and customer-contributing processes across the Canadian marketplace. The presentation focuses on developing a deep
         understanding of centralized, corporate, distributed, and independent customers; and change management, both internal and external,
         necessary	in	influence	activities.		Participants	will	take	away	these	tangible	actions:
         •	 Use	the	framework	of	joint	customer	value	creation	to	find	opportunities	and	drive	customer	involvement
         •	 Identify and address internal and external complexity in customer-contributing processes
         •	 Manage internal compliance-focused stakeholders while still delivering value to the business and customers
         •	 Influence	internal	and	external	processes,	including	those	owned	by	your	customer
         •	 Think through customer and employee impact when designing business and IT controls
         Speaker:
         David Haigh, Sr. Process Excellence Manager, Johnson & Johnson Inc. (Canada)

4:00     ROUND TABLE DISCUSSIONS: GROUP THERAPY INTERACTIVE SESSION
         This session has been constructed to help increase dialog and knowledge transfer between leading industry experts, solution providers
         and organizations. To facilitate this learning, the session leader will begin with a few suggestions of major challenges related to culture and
         open it up to the audience. The “group therapy” learning format opens the lines of communication and is designed for speakers, delegates
         and	service	providers	alike.		The	goal	of	this	session	is	to	share	specific	cultural	challenges	and	ideas	and	learn	from	one	another.		
         •	 Please come prepared with your questions and challenges in a rare opportunity to exchange knowledge and ideas with some of the
            greatest minds in this space
         Group Therapy Leader:
         Charles Aubrey,Vice President, Anderson Pharmaceutical Packaging

5:50     CHAIRPERSON’S CLOSING REMARKS AND END OF CONFERENCE

 ABOUT OUR SPONSOR:
 Waters®	Laboratory	Informatics	is	a	software	solution	for	scientific	data	
 management, network integration, and compliance management. Our Informatics
 solutions have helped leading pharmaceutical, environmental, food and beverage,
 and chemical organizations reduce R&D costs, accelerate decision making, improve
 laboratory effectiveness, and get products to market faster.


1-800-882-8684 | info@iqpc.com | www.LSSPharma.com                                                                                                    7
Join our global online community
                                                                                                                                    and download exciting new webinars and
                                                 is pleased to announce the                                                         podcasts developed by industry leaders for IQPC.


                                                                                                                Register by 12/16/11 to receive the lowest available price!
13th Annual                                                                                                                                    See page below.




Lean Six Sigma
for Pharmaceutical, Biotech,
and Medical Device Excellence
February 21-23, 2012 | Atlanta, GA                                                                                                 5 Easy Ways to Register Now!
                                                                                                                                   Web:        www.lsspharma.com
                                                                                                                                   Email:      info@iqpc.com
  PLEASE REGISTER ME FOR:
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  q     Please keep me informed via email about this and other related events.
  q     Check enclosed for $ ____________________(Payable in US Dollars to IQPC)
  Please charge my: q AmEx   q Visa q MasterCard q Discover
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  Registration Information                                                                                       Location and Lodging Information:
                                                                                                                 As soon as a specific venue is confirmed we will post the
                                                                                                                 information online. If you would like to be notified via email as soon
   Industry Pricing                          Register by           Register by            Standard               as the information becomes available please email info@iqpc.com
                                             12/16/2011            1/20/2012                                     with the following in the subject line: LSS Pharma Venue Request.

   All-Access Pass                               $1,899                $2,499                $2,699
                                               Save $1,547            Save $947             Save $747         MAKE CHECKS PAYABLE TO: IQPC
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                                                                                                              *CT residents or people employed in the state of CT must add 6% sales tax.
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                                               Save $1,447            Save $947             Save $747
                                                 $1,799                $2,099                $2,299           Payment Policy: Payment is due in full at the time of registration and includes
   Conference Only                                                    Save $200                               lunches and refreshments. Your registration will not be confirmed until payment is
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   Workshop Day                                                        $549                                   and Substitution Policy, please visit www.iqpc.com/cancellation

  All-Access Pass includes the 2 day main conference and all workshops. Please note multiple discounts        Special Dietary Needs: If you have a dietary restriction, please contact Customer
  cannot be combined. A $99 processing charge will be assessed to all registrations not accompanied by        Service at 1-800-882-8684 to discuss your specific needs.
  credit card payment at the time of registration. Call for team discounts.
                                                                                                              ©2011 IQPC. All Rights Reserved. The format, design, content and arrangement of
  A end user qualifies as a professional working for pharmaceutical, biotech or medical device company that
  is looking for solutions to improve their Lean Six Sigma operations.                                      this brochure constitute a trademark of IQPC. Unauthorized reproduction will be
                                                                                                              actionable under the Lanham Act and common law principles.
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  and medical device industry.


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13th Annual Lean Six Sigma For Pharmaceutical, Biotech And Medical Device Excellence

  • 1. NEW FOR 2012: is pleased to announce the Breakout Sessions Personalize Your Agenda 13th Annual Lean Six Sigma for Pharmaceutical, Biotech, and Medical Device Excellence Advancing Continuous Improvement Learn case studies & best practices from these leading industry experts: and Innovation within Your Organization Hillary M. Wilson Michael McSweeney Business Operations Senior Operational February 21-23, 2012 | Atlanta, GA Lead, Pradaxa Marketing Boehringer Ingelheim Excellence – LSS Master Black Belt Pharmaceuticals, Inc. GlaxoSmithKline www.LSSPharma.com Terence Barnhart Lyndi Cole TOP REASONS TO ATTEND: Senior Director Operational Create your own personalized conference agenda by selecting Pfizer Worldwide R&D Excellence Expert GlaxoSmithKline among our featured plenary & breakout session topics: • Culture & • Optimized LSS Brian Eden Management Buy-in Project Portfolio Paul Nelson Senior Director and • Lean & Six Sigma Trends • Supplier Integration Supply Chain Senior Global Head, Operational Director & Lean Excellence • Research & Development • Sales & Marketing Sigma Leader Mylan (R&D) • Lean A3 Problem Solving Shire Pharmaceuticals Pharmaceuticals • Lean Innovation Method Inc. • Regulatory Compliance • Manufacturing Winston Brown • Capital Improvements • Silos Charles Aubrey Director, Global Quality Vice President of Quality Compliance • Strategic Supplier • Benchtop Equipment Baxter HealthCare Partnerships Selection and Lean Six Sigma Anderson Corporation • Employee Engagement • Regulated QC Pharmaceutical • Mature Programs/ Laboratory Packaging William Favier Projects • Lean Laboratory Director, • Mergers/Acquisitions • Packaging Lean Sigma Training Deepa Kumar Bristol-Myers Squibb • Knowledge & Change • TPS Pillar of Jidoka Operational Co. Management Excellence Expert GlaxoSmithKline Register by 12/16/11 to receive the lowest available price! Nick Ruhmann Continuous Improvement See page 8 Diane Francisco Leader, Master Black Belt Director of Process BD Medical - Excellence, Global Diabetes Care Commercial Organization Follow Covance our expert Kelly Kujan Vice President of speakers on: Continuous Improvement David Haigh, Sr. Sponsor: Media Partners: Process Excellence Fenwal Inc. Manager Johnson & Johnson Inc. AND MANY MORE. . . . (Canada) 1-800-882-8684 | info@iqpc.com | www.LSSPharma.com
  • 2. 13th Annual Lean Six Sigma WHO WILL YOU NETWORK WITH? Champions, Master Black for Pharmaceutical, Biotech, Belts, Black, Green, Belts Executive/ Senior Vice and Medical Device Excellence Presidents,Vice Presidents, Directors, Project Coordinator, Managers, Heads and leaders of: Dear Colleague, • Lean Six Sigma • Process Excellence IQPC is proud to present the 13th Lean Six Sigma for Pharmaceutical, Biotech and Medical • Operational Excellence Device Excellence Conference. For the first time on the East Coast this event will feature • Business Excellence breakout sessions designed to provide additional content for delegates to choose from. • Continuous Improvement • Knowledge & Personalize your conference agenda and tackle your biggest hurdles and areas of interest. Change Management You will hear over 28+ in-depth case studies and workshops bringing you innovative solutions • Strategy Management addressing top industry concerns including: • QA/QC • Analyzing the latest and upcoming trends in this industry • Research & • Deploying LSS in a regulated business Development • Utilizing lean six sigma throughout your entire organization - • Clinical Trials beyond manufacturing • Sales & Marketing • Manufacturing • Selecting and resourcing the optimized LSS project portfolio • Engineering • Building vendor partnerships & becoming strategic with your suppliers • Innovation • Achieving sustainability and success through knowledge & change management • Validation • Fostering a culture of continuous improvement and understanding the value of • Regulatory Compliance employee engagement • Information Technology • Opportunities in the regulated QC laboratory • Supply Chain • Applying the Lean A3 problem solving method • Logistics • Supplier Quality • Addressing the next steps for mature six sigma & lean projects/programs • Accounting/Finance • Implementing lean innovation: a framework to improve efficiency & effectiveness of • Packaging the innovation process • Laboratory See who Additionally, this event offers interactive networking opportunities and sessions. This is your attended previous opportunity to share specific challenges affecting your organization, exchange contact information events here. and learn from knowledgeable leaders in this space. Be sure to register yourself and a team of key people for this important event today. Don’t miss this chance to Join our e benchmark against developing and proven strategies. P.S. Attend th global online MUST SEE community Sincerely, pre-conference and download d to workshops designe exciting new address challen ges and webinars and diate come up with imme podcasts developed Claudia Rubino actionable so lutions! by industry leaders Program Director See page 3. for IQPC. Six Sigma & Process Excellence IQ, division of IQPC Claudia.Rubino@IQPC.com SPONSORSHIP & EXHIBITION OPPORTUNITIES About the organizer: Six Sigma IQ, a division of Event sponsorship is an excellent opportunity for your company to showcase its products and IQPC, provides useful services to high-level, targeted decision makers attending the 13th Lean Six Sigma for training courses, conference Pharmaceutical, Biotech & Medical Device Excellence Conference. IQPC and Six Sigma & and expositions for Process Excellence IQ help companies like yours achieve important sales, marketing, and branding pharmaceutical executives to objectives by setting aside a limited number of event sponsorships – all of which are tailored to assist network and learn your organization in creating a platform to maximize its exposure at the event. For more information the latest pharma business development and on sponsoring at this or upcoming events, please contact Kimberly Sun at (212) 885-2662 or trends occurring in Kimberly.Sun@iqpc.com. organizations today. 2 1-800-882-8684 | info@iqpc.com | www.LSSPharma.com
  • 3. Pre – Conference Workshops Tuesday, February 21, 2012 Our series of workshops have been designed to translate winning strategies from leading experts and develop them into tangible benefits you can take away and implement within your own company’s procedures. Join the 13th LSS for Pharmaceutical, Biotech, Medical Device Excellence resourceful workshops to enhance your expertise. A 8:00am – 10:30am 7:30am Registration for Workshop A (Refreshments will be served) SELECT AND RESOURCE THE OPTIMIZED LSS PROJECT PORTFOLIO Projects for Process Improvement are often selected individually, on the merit of each • How to aggregate resources required for the portfolio project. While this works on the project level, it does not lead to a successful program of • How to select the portfolio that maximizes attainment of Process Improvement within the company. The portfolio of projects needs to be viewed company goals as a whole, and individual projects added to it in a way that links with company strategic • How to ensure that the resources are in place to carry out the goals. Also, the resources may not be in place and available to successfully complete portfolio of projects all projects, or there may be overlap between projects that create problems. For the How you will benefit: Process Improvement program to be successful, project selection must be done as part of • Maximize the odds that your projects achieve their goals Portfolio Management. Developing the optimal portfolio is the goal of this workshop: • Reduce frustration among overworked team resources What will be covered: • Be able to see the big picture of what your Process Improvement • How to evaluate single projects program is doing • How to link individual project goals to company goals • Maximize the value of the portfolio of projects to the company • How to identify inter-dependencies between projects • How to detail the resource needs of a project Your Workshop Leader: Dr. Mark Gershon, SSMBB, President, World Class Training Institute B 11:00pm -1:30pm LEAN A3 PROBLEM SOLVING METHOD 10:45am Registration for Workshop B (Boxed Lunches will be Served) Much more than just a tool, A3 Problem Solving is a simple method to systematically • An intuitive and easy way to learn and remember help define and solve problems. This workshop will explore a way of thinking that causes How you will benefit: entire teams of people to sharply focus their minds on the foundational Lean ways • Improve your ability to define and solve problems of seeing process flows and wastes, constantly redirecting their attention back to the • Teach managers how to better coach, mentor, and lead foundational lean teachings: • The A3 method offers a long-missing standardized approach to solving What will be covered: problems identified in higher-level value stream maps • Simple and consistent way to achieve and document root cause analysis Your Workshop Leaders: • Create the target condition Terence Barnhart, Senior Director, Pfizer Worldwide R&D C 2:00pm – 4:00pm 1:45pm Registration for Workshop C (Refreshments will be served) THE FALLEN TEMPLE – HOW THE TPS PILLAR OF JIDOKA IS MORE THAN JUST AUTONOMATION This discussion will center on research completed by notable author and MIT lecturer How you will benefit: Steven Spear and how it was incorporated by Toyota into their supplier training in regard • Gain a better understanding of the Jidoka Pillar, and how ignoring it causes to the lack of understanding of the Jidoka Pillar by western companies. Analyze how a stagnation in the ability to be “Just in Time” focus on the visible aspects of Toyota have created a gap in the understanding of Lean and • Understand the capabilities we as leaders should be propagating in all employees resulted in the stagnation of many companies Lean journey. • Actual Gemba Kaizen - apply the principles on our host location before leaving! What will be covered: Your Workshop Leader: • Error prone vs. high performance systems Nick Ruhmann, Continuous Improvement Leader, Master Black Belt, • Capabilities of the operational outstanding BD Medical – Diabetes Care • True north (ideal state) • The FOUR levels of process design D 4:30pm – 6:30pm 4:15pm Registration for Workshop D LEAN INNOVATION: A FRAMEWORK TO IMPROVE EFFICIENCY & EFFECTIVENESS OF THE INNOVATION PROCESS Most Lean implementations have been used to reduce waste in operations. Deploying What will be covered: Lean has led to cost savings and excess capacity in equipment and human resources. • Learn the innovation framework consisting of fundamental business strategy Leadership and stakeholders expect financial returns. Utilizing Lean aggressively for • Incentives for inspiration, rules of creativity and types of thinking reducing waste has also resulted in ignorance of the need for business growth requiring • Analysis of the phases of an innovation methodology innovation. Hence Lean without innovation would result in profit in a shrinking business. How you will benefit: This scenario does not appear a viable solution for businesses in the long. Operational • Utilize TEDOC methodology for innovative deployment of lean for better performance accounts for about 10% of the corporate performance. In order to outcomes and for developing new products or solutions for revenue growth maximize benefits of Lean Six Sigma, corporations must focus on business development • Take away a better understanding of Lean Six Sigma Assessment Tool by introducing new products or services. Lean Innovation is a framework that improves • Discover a simple yet powerful creativity process efficiency and effectiveness of the innovation process based on best practices of great • Make use of lean innovation methodology and innovative ideas for current innovators. Lean Innovation framework reduces waste in the innovation process project(s) at work in your organization for accelerating innovation and increasing return on investment in innovation. This way additional capacity is utilized for realizing business growth instead of downsizing Your Workshop Leader: businesses. This workshop will assess their Lean Six Sigma initiatives and corporate Praveen Gupta, President, Accelper Consulting performance, use ideation process in lean deployment, and practice creativity: 1-800-882-8684 | info@iqpc.com | www.LSSPharma.com 3
  • 4. MAIN CONFERENCE DAY 1 Wednesday, February 22, 2012 8:00 REGISTRATION AND COFFEE 8:50 CHAIRPERSON’S WELCOME AND OPENING REMARKS TRENDS & DEVELOPMENTS WITHIN LEAN/SIX SIGMA WORLD 9:00 KEYNOTE/PANEL DISCUSSION: WHAT LIES AHEAD: DISCUSSING TOP TRENDS AND DEVELOPMENTS The pharmaceutical, biotech & medical device industries have seen the initial benefits of implementing six sigma & lean processes and techniques into their everyday operations. With many of these programs finally seeing some initial benefits and drawbacks and as the stories of successes and failures continue to be shared, many business improvement professionals are wondering which direction the trends and development within this space heading. This panel discussion will focus on: • What is new in Lean Six Sigma • What new trends and old trends continue • Have any activities failed and gone by the wayside • How to expand the applications outside of production (labs, R&D, etc) • Practices or approaches being adopted from other industries • Tools or programs that are standing the test of time and really sustaining excellence • How to streamline and control the phases of improvement projects Panelists: Dr. Mark Gershon, SSMBB, President, World Class Training Institute Charles Aubrey,Vice President, Anderson Pharmaceutical Packaging 9:45 CASE STUDY: “THE NEED FOR SPEED” In today’s fast-paced environment many of us are struggling with how to use the Lean and Six Sigma tools and approaches we grew up with (which are now 50-60 years old) to meet the speed demanded by our businesses. We’ll explore why things are going faster, some orthodoxies that need to be reexamined in light of the changing environment, give specific examples of how some basic Lean Sigma tools and approaches can be tweaked and adjusted to speed up the process and discuss how the “democratization of learning” can be leveraged to make organizations more responsive. Here you will: • Understand todays business and its fast paced environment • Learn a step by step approach to improving your current operations • Determine the best tools and approaches to increase the speed of your operation Speaker: William Favier, Director, Lean Sigma Training, Bristol-Myers Squibb Co. John Ghidiu, Certified Six Sigma Black Belt (ASQ), Certified Performance Technologist (ISPI), Certified Professional in Learning and Performance (ASTD) 10:30 MORNING NETWORKING AND REFRESHMENT – CARD EXCHANGE PACKAGING/MANUFACTURING SALES & MARKETING 11:15 CASE STUDY: APPLYING INNOVATION TO CASE STUDY: DEPLOYING LEAN SIX SIGMA IN A SALES PHARMACEUTICAL PACKAGING: AND MARKETING ORGANIZATION BETTER PATIENT OUTCOMES Implementation of Lean Six Sigma (LSS) in contract service companies Innovation is the key to success for any business. Determining the best way would not be considered to be novel or new these days. Service to apply this concept within your operations and procedures will be an companies have embraced this structured approach for continuous essential and crucial step to continuous improvement. Join us in analyzing improvement of their key operational processes. They have shown success Anderson Pharmaceutical Packaging’s development, implementation and in reducing cycle time, improving quality and creating value for their assessment of their innovation initiative within their packaging department, customers and businesses. With all of this success, one might assume that and analyzing the keys benefits and lessons learned throughout their LSS would be practiced in all areas of the organization. This assumption journey. This case study will: however would be false. Sales and Marketing were areas that LSS was • Review the various innovation methods: Design for Six Sigma, believed to not be applicable. It is only recently that deployment of LSS in Blue Ocean and TRIZ Sales and Marketing groups has been seen as a value add. Key points that • Discuss the process to convert innovations to patents will be discussed include: • Demonstrate how patented products can be commercialized • Get your foot in the door: Put process excellence and improvement in • Show how the develop investment and commercialized front of mind for management in all strategy innovations realize significant payback • Develop a deployment roadmap or plan that meets the needs of the • Prove how the innovations provide better health outcomes for patients Sales and Marketing groups, while taking in to consideration the group Speaker: cultures Charles Aubrey,Vice President, Anderson Pharmaceutical Packaging • Achieve organizational alignment between leadership targets and improvement goals for maximum project impact • Develop a flexible, yet standard, framework for scoping, prioritizing and executing improvement projects Speaker: Diane Francisco, Director of Process Excellence, Global Commercial Organization, Covance 12:00 CASE STUDY: MEASUREMENT SYSTEM ANALYSIS (MSA) CASE STUDY: BEST PRACTICE – ASSESSING OPERATIONAL FOR BENCHTOP EQUIPMENT SELECTION IMPROVEMENT OPPORTUNITIES FOR PHARMACEUTICAL This is a case study based on a project that allowed the GSK SALES & MARKETING TEAMS Biopharmaceutical manufacturing group to choose benchtop equipment This presentation will review methods for assessing productivity (such as those used to assay in-process test samples) to better suit the improvement opportunities in sales and marketing. The presentation needs warranted by the drug substance manufacturing process. In the past focuses on designing the assessment approach, assessing benefit and effort, such decisions were not always made using a statistically driven approach. and gaining key stakeholder alignment. Attendees will receive a long list of You will learn to: potential places to look within their organizations to identify. 4 1-800-882-8684 | info@iqpc.com | www.LSSPharma.com
  • 5. MAIN CONFERENCE DAY 1 Wednesday, February 22, 2012 • Use of the DMAIC methodology with a cross functional team to • Gotta take 10% out of your budget and still do all the same understand process / customer requirements for the assay in question work: Address this situation at your company • Design appropriate Measurement Systems Analysis experiments • Marketing stakeholder management in an environment that is involving equipment/instruments, analysts, number or samples, resistant to change replicates, etc. to obtain enough data to be studied • Pharma marketing agencies – setting new expectations of • Employ statistics to understand variability of each piece of productivity equipment for the manufacturing process Speaker: • Implement a weighted matrix approach using the statistical data Hillary M. Wilson, Business Operations Lead, Pradaxa Marketing, to make decisions on equipment selection Boehringer Ingelheim Pharmaceuticals, Inc. Speaker: Deepa Kumar, Operational Excellence Expert, GlaxoSmithKline Lyndi Cole, Operational Excellence Expert, GlaxoSmithKline 12:45 NETWORKING LUNCHEON 1:45 CASE STUDY: ENSURE VALIDATION THROUGHOUT YOUR PRODUCT LIFECYCLE With an ultimate goal of eliminating waste, Kaizen focuses on improving standardized activities and processes. When used appropriately, this method can be utilized to standardize an organization’s operations leading to improved quality and greater productivity. Join us in highlighting the steps to a successful Kaizen implementation. You will learn to: • Implement continuous process improvement in manufacturing, engineering, supporting business processes, supply chain and management • Clarify the steps required to standardize an operation • Measure a standardized operation and standardizing the new, improved operations • Highlight innovative approaches to meet requirements and increase productivity Speaker: Winston Brown, Director, Global Quality Compliance, Baxter HealthCare Corporation 2:30 CASE STUDY: OPPORTUNITIES FOR LEAN SIX SIGMA IN CASE STUDY: ACHIEVE RESULTS THROUGH BUSINESS THE REGULATED QC LABORATORY PROCESSES & CORPORATE FUNCTIONS Once the primary domain of manufacturing operations, Lean Six Sigma Integrating Lean Six Sigma throughout an organization’s core business approaches are now penetrating analytical quality testing laboratories and operations to achieve early benefits and full self-sustainability necessitates Quality Assurance (QA) organizations. As economic imperatives coupled a strong focus on core business processes and corporate functions. In this with cultural shifts and technological advancements prevail over the session, you will learn real examples on how to use Lean and Six Sigma to historical aversion to change in these regulated environments, more Lean create agile business processes and to ensure your organization’s survival is Six Sigma projects are moving from the perimeter of laboratory operations this through economic and competitive environment. This case study will deeper into QC workflows. This case study will: teach you to: • Ensure data is captured completely and correctly to support • Assess both internal and external business processes regulatory compliance • Analyze successful practices to streamline business processes & • Use integrated laboratory informatics systems for traceability of corporate functions batch record information, laboratory assets, analytical testing • Address common difficulties and drawbacks data, reports, etc. • Develop a step by step approach towards effecting change • Highlight the incorporation of procedure-based workflows into • Explore common difficulties and drawbacks laboratory execution systems (LES) Speaker: Speaker: Terence Barnhart, Senior Director, Pfizer Worldwide R&D Cozette Cuppett, Senior Informatics Marketing Manager, Americas, Waters Corporation 3:15 AFTERNOON NETWORKING AND REFRESHMENT BREAK 4:00 BUSTING THROUGH THE SILOS: CONNECTING THE FULL VALUE STREAM Creating a meaningful and sustainable culture of excellence requires connecting all of the “dots” to drive superior value for the customer. Too often, continuous improvement programs experience a drop off in benefit or “hit the wall” once a manufacturing site or distribution center has optimized its core processes. Driving to the next level of transformation requires that all of the supporting transactional areas adhere to the core principles of a “LEAN Enterprise”, it simply requires practitioners to translate the work to a new environment. Join us for this interactive conversation designed to help with the translation to create outstanding results. • How can your organization move from a vertical to horizontal view • How you can approach the deployment of LEAN in your transactional areas • Understand what will be required from your Leadership to support the change • Gain 3-4 practical ideas that you can immediately apply to your situation William Owad, SVP, Operational Excellence, Cardinal Health 4:45 BUILD VENDOR PARTNERSHIPS AND BECOME STRATEGIC WITH YOUR SUPPLIERS Developing a door-to-door (D2D) product value stream requires extending the value stream to include your vendors. Do you know your vendor’s process capabilities and value streams? The answer to both of these questions will have a direct impact on your current vendor partnership and will become the base on which to begin building a strategic approach with your suppliers. This session will focus on: • Developing Value Stream Maps (VSM) for each BOM component (start with “runners”) • Future State VSM identifies continuous improvements projects • Both you and vendor focused on same projects • Develop visual controls and metrics • Quality assurance reduced testing project • Risks identified and assessed (single source, specialty items, long lead times, and etc) • Replenishment strategies (vendor managed inventory, consignment stock, supplier hubs, kanbans) Speaker: Michael McSweeney, Senior Operational Excellence – LSS Master Black Belt, GlaxoSmithKline 5:30 Please join us for opportunity to exchange contact information with all delegates, speakers and sponsors. Expand Take advantage of this opportunity to expand your network and gain quality contacts within you field. your Lean P.S. Please bring your business cards!!! Six Sigma 5:50 END OF MAIN CONFERENCE DAY 1 network. 1-800-882-8684 | info@iqpc.com | www.LSSPharma.com 5
  • 6. MAIN CONFERENCE DAY 2 Thursday, February 23, 2012 7:55 REGISTRATION AND COFFEE 8:25 CHAIRPERSON’S RECAP OF MAIN CONFERENCE DAY 1 CULTURE/MANAGEMENT BUY-IN 9:00 KEYNOTE/PANEL DISCUSSION: ADDRESS CULTURE & MANAGEMENT BUY-IN This session has been constructed to help increase dialog and knowledge transfer between leading industry experts and provide key experiences addressing culture and management buy-in. To facilitate this learning, the session leader will begin with a few suggestions of major challenges related to culture and open it up to the audience. This panel/learning format opens the lines of communication and is designed for speakers, delegates and service providers alike. The goal of this session is to share specific cultural challenges and ideas and learn from one another. • Determine the keys to establishing effective culture changes • Market stakeholder management in an environment that is resistant to change Panelists: Brian Eden, Senior Director and Global Head, Operational Excellence, Mylan Pharmaceuticals Kelly Kujan,VP of Continuous Improvement, Fenwal Inc. Hillary M. Wilson, Business Operations Lead, Pradaxa Marketing, Boehringer Ingelheim Pharmaceuticals, Inc. 9:45 CASE STUDY: THE VALUE OF EMPLOYEE ENGAGEMENT – HOW TO TURN 600 PEOPLE INTO 4000+ IMPROVEMENTS See how a Becton Dickinson plant has turned all 600 of its employees into problems solvers and waste eliminators, and continued to increase both the quality and quantity of the ideas submitted with minimal investment. Understand the important difference between a “suggestion program” and a “kaizen” program, both in the impact to the company, and to individuals thinking habits. This case study will teach you to: • Handle a large volume of kaizen ideas through gradual use of manual to IT solutions • How to keep the program increasing quality and quantity every year • How a rewards system can help to motivate “exceptional” kaizens and identify stand out employees • Think of kaizens as problem solving practice for every employee • To use kaizen’s as a coaching / mentoring opportunity to increase management / shop floor cooperation. Speaker: Nick Ruhmann, Continuous Improvement Leader, Master Black Belt, BD Medical - Diabetes Care Gert Coetzer, Lean Coordinator, BD Medical - Diabetes Care 10:30 MORNING NETWORKING AND REFRESHMENT BREAK - DO YOU NEED TO… (VENDOR SOLUTIONS) A HOLISTIC VIEW 11:15 CASE STUDY: THE STRATEGY OF OPERATIONAL EXCELLENCE Join us in exploring a case study focusing on strategic questions. Every organization must be able to answer key questions in order to ensure effective operational excellence programs and procedures. This case study will focus on: • Does your Lean/Six Sigma program support the corporate mission? • What are your bench marks? • How do you know your Lean/Six Sigma program is working? Is it sustainable? • What gaps need to be filled – Short term? Long term? Speaker: Paul Nelson, Operational Excellence Leader, Shire Pharmaceuticals Inc. 12:00 CASE STUDY: MANAGING CHANGE IN LEAN SIX SIGMA DEPLOYMENTS IN HIGHLY REGULATED ENVIRONMENTS Continuous improvement deployments can be fragile. One key to their successful uptake is cultivation of strong sponsorship and proper management of natural resistance to the changes the improvement work will bring. Resistance to change is natural in all areas of continuous improvement application. Highly regulated industries such as food and pharmaceuticals have specific considerations in this regard. This session will focus on: • Methods to assess, cultivate and sustain sponsorship for continuous improvement work • Lessons learned from deployment work in food and pharmaceutical continuous improvement start ups • Questions, answers and sharing from the larger group on what works, what doesn’t work, and tips and tricks to manage complex change landscapes Speaker: Brian Eden, Senior Director and Global Head, Operational Excellence, Mylan Pharmaceuticals 12:45 NETWORKING LUNCHEON 6 1-800-882-8684 | info@iqpc.com | www.LSSPharma.com
  • 7. MAIN CONFERENCE DAY 2 Thursday, February 23, 2012 POST IMPLEMENTATION: ASSESS THE RESULTS 1:45 PANEL DISCUSSION: WHAT’S NEXT? TAKE THE NEXT STEP WITH PROJECT & PROGRAMS APPROACHING OR ALREADY IN A MATURE STATE As many organization’s programs/projects for business Performance Excellence move into a mature state, many fail to deliver on the dream of establishing a culture of continuous improvement. When the obvious waste and the initial opportunities have been tackled, where do you look next? When the enthusiasm and interest of the executive team is waning, how can you revive your project/program and renew interest? This session will focus on: • Step by step overview of the entire continuous improvement process • Reviving your team and gaining executive team support • Continuous improvement processes across departments Speaker: Nick Ruhmann, Continuous Improvement Leader, Master Black Belt, BD Medical - Diabetes Care Brian Eden, Senior Director and Global Head, Operational Excellence, Mylan Pharmaceuticals 2:30 CASE STUDY: LARGE SCALE MERGER: DETERMINE THE NEXT STEPS Lean Six Sigma can offer a number of techniques that can quickly yield operational insights at all stages of the merger & acquisition process, from due diligence through integration and beyond. Management needs to understand and view the application of six sigma as a catalyst to the M&A process, and not as an added work & cost. This case study will highlight the strategic approach taken by Covance when facing the daunting task of merging two organizations into one streamlined efficient operating machine. You will learn to: • Assess current processes, strategies and goals for both organizations • Accelerate through the use of tools integrated through this strategic partnership • Understand the pitfalls and complication resulting from a large scale merger • Align both organization’s goals and processes Speaker: Kelly Kujan,VP of Continuous Improvement, Fenwal Inc. 3:15 AFTERNOON NETWORKING AND REFRESHMENT BREAK CHANGE/KNOWLEDGE MANAGEMENT 4:00 CASE STUDY: CHANGE MANAGEMENT: INFLUENCING CUSTOMER-FACING AND CUSTOMER-CONTRIBUTING PROCESSES This presentation will cover a series of case studies, describing recent successes at Johnson & Johnson affiliates to improve their customer-facing and customer-contributing processes across the Canadian marketplace. The presentation focuses on developing a deep understanding of centralized, corporate, distributed, and independent customers; and change management, both internal and external, necessary in influence activities. Participants will take away these tangible actions: • Use the framework of joint customer value creation to find opportunities and drive customer involvement • Identify and address internal and external complexity in customer-contributing processes • Manage internal compliance-focused stakeholders while still delivering value to the business and customers • Influence internal and external processes, including those owned by your customer • Think through customer and employee impact when designing business and IT controls Speaker: David Haigh, Sr. Process Excellence Manager, Johnson & Johnson Inc. (Canada) 4:00 ROUND TABLE DISCUSSIONS: GROUP THERAPY INTERACTIVE SESSION This session has been constructed to help increase dialog and knowledge transfer between leading industry experts, solution providers and organizations. To facilitate this learning, the session leader will begin with a few suggestions of major challenges related to culture and open it up to the audience. The “group therapy” learning format opens the lines of communication and is designed for speakers, delegates and service providers alike. The goal of this session is to share specific cultural challenges and ideas and learn from one another. • Please come prepared with your questions and challenges in a rare opportunity to exchange knowledge and ideas with some of the greatest minds in this space Group Therapy Leader: Charles Aubrey,Vice President, Anderson Pharmaceutical Packaging 5:50 CHAIRPERSON’S CLOSING REMARKS AND END OF CONFERENCE ABOUT OUR SPONSOR: Waters® Laboratory Informatics is a software solution for scientific data management, network integration, and compliance management. Our Informatics solutions have helped leading pharmaceutical, environmental, food and beverage, and chemical organizations reduce R&D costs, accelerate decision making, improve laboratory effectiveness, and get products to market faster. 1-800-882-8684 | info@iqpc.com | www.LSSPharma.com 7
  • 8. Join our global online community and download exciting new webinars and is pleased to announce the podcasts developed by industry leaders for IQPC. Register by 12/16/11 to receive the lowest available price! 13th Annual See page below. Lean Six Sigma for Pharmaceutical, Biotech, and Medical Device Excellence February 21-23, 2012 | Atlanta, GA 5 Easy Ways to Register Now! Web: www.lsspharma.com Email: info@iqpc.com PLEASE REGISTER ME FOR: q WORKSHOP A q WORKSHOP B q WORKSHOP C Phone: 1-800-882-8684 or q WORKSHOP D q CONFERENCE ONLY q ALL-ACCESS PASS Fax: 646-378-6025, 24 hours a day Mail: IQPC, 535 5th Avenue, Name_________________________________________________________________________ 8th Floor, New York, NY 10017 JobTitle_________________________________________________________________________ Organization___________________________________________________________________________________________________________________ Address__________________________City___________________________________________State/Province __________________________________ Country _______________________________________________ Zip/PostalCode__________________________________________________________ Phone_________________________________________________________Fax____________________________________________________________ E-Mail________________________________________________ Approving Manager_______________________________________________________ q Please keep me informed via email about this and other related events. q Check enclosed for $ ____________________(Payable in US Dollars to IQPC) Please charge my: q AmEx q Visa q MasterCard q Discover Card #___________________________________________________________________Exp Date:______ /_______CVM Code:______________________ q I cannot attend, but please keep me informed of all future events. Event #10490.012 Registration Information Location and Lodging Information: As soon as a specific venue is confirmed we will post the information online. If you would like to be notified via email as soon Industry Pricing Register by Register by Standard as the information becomes available please email info@iqpc.com 12/16/2011 1/20/2012 with the following in the subject line: LSS Pharma Venue Request. All-Access Pass $1,899 $2,499 $2,699 Save $1,547 Save $947 Save $747 MAKE CHECKS PAYABLE TO: IQPC Conference Only $999 $1,599 $1,799 A $99 processing charge will be assessed to all registrations not accompanied by Save $800 Save $200 credit card payment at the time of registration. *CT residents or people employed in the state of CT must add 6% sales tax. Workshop Day $549 Details for making payment via EFT or wire transfer: JPMorgan Chase Vendor Pricing Register by Register by Standard Penton Learning Systems LLC dba IQPC: 957-097239 12/16/2011 1/20/2012 ABA/Routing #: 021000021 Reference: Please include the name of the attendee(s) and the event All-Access Pass $2,499 $2,999 $3,199 number: 10490.012 Save $1,447 Save $947 Save $747 $1,799 $2,099 $2,299 Payment Policy: Payment is due in full at the time of registration and includes Conference Only Save $200 lunches and refreshments. Your registration will not be confirmed until payment is Save $500 received and may be subject to cancellation. For IQPC’s Cancellation, Postponement Workshop Day $549 and Substitution Policy, please visit www.iqpc.com/cancellation All-Access Pass includes the 2 day main conference and all workshops. Please note multiple discounts Special Dietary Needs: If you have a dietary restriction, please contact Customer cannot be combined. A $99 processing charge will be assessed to all registrations not accompanied by Service at 1-800-882-8684 to discuss your specific needs. credit card payment at the time of registration. Call for team discounts. ©2011 IQPC. All Rights Reserved. The format, design, content and arrangement of A end user qualifies as a professional working for pharmaceutical, biotech or medical device company that is looking for solutions to improve their Lean Six Sigma operations. this brochure constitute a trademark of IQPC. Unauthorized reproduction will be actionable under the Lanham Act and common law principles. A vendor qualifies as equipment, technology or service providers to the pharmaceutical industry, biotech, and medical device industry. 1-800-882-8684 | info@iqpc.com | www.LSSPharma.com 8