"Lean Six Sigma & Process Improvement for Customer Experience

Take advantage of the All Access Package and SAVE up to $1,745 (see page 2 for details) 9th Lean Improving Organizational Performance While Reducing Six Sigma Operational Costs February 22-24, 2010 for Pharmaceutical, The Hyatt at Bellevue, Philadelphia, PA Biotech, and Medical Learn from Industry Experts Including: Device Excellence Lyndi Gillespie, Operational Excellence Expert, GlaxoSmithKline Biopharm Deepa Kumar, Biopharmaceutical Global Manufacturing & Supply, GlaxoSmithKline Don’t Miss the Newly Designed 2010 Kim Palladino, Operational Excellence Expert, GlaxoSmithKline Program with 4 Tailored Modules for Paul Nelson, Supply Chain Senior Director the Life Science Industry: and Lean Transformation Leader, Shire Pharmaceuticals Inc Kevin D. Cluff, Ph.D., P.E., Global Pharmaceutical R&D, Abbott Laboratories Module 1: Reducing Operational Cost Charles Aubrey, Vice President Performance Excellence, Anderson Pharmaceutical Packaging Thomas Bertels, Partner, Valeocon Module 2: Mario Roman, Operational Excellence Principal, Genentech Continuous Improvement Keith Russell, PhD., Global Lean Sigma Director, AstraZeneca 9th LSS Gill Eapen CFA, Founder and Managing Principal, Decision Options, LLC Bruce Sawyer, Senior Director, Module 3: Global Business Excellence, GPSG, Johnson & Speeding up R&D Johnson Bill Bolding, VP Operations and Process Improvement, Tunnell Consulting Module 4: Bryan Winship, Managing Consultant, Organizational Performance Tunnell Consulting Jeff Slutsky, Global Director of DFSS, Bausch&Lomb Inc. Sponsors: Media Partners: CanBiotech R&D Outsourcing Capital Sourcing Competitive Intelligence 1-800-882-8684 | www.lsspharma.com

9th Lean for Pharmaceutical, Biotech, Six Sigma and Medical Device Excellence Who Should Attend? Champions, Master Black Belts, Black, Green, Yellow, Dear Colleagues, and Red Belts Executive / Senior Vice Presidents, Vice Presidents, Directors, Managers, and leaders of: Lean Six Sigma has never been in greater demand in the pharmaceutica • Process Excellence • Validation industry. Companies are embracin l and life science g the powerful statistics and process-d • Operational Excellence • Research & that aim to radically improve processes riven methodology throughout the organization and redu • Business Excellence Development attempt to boost earnings without ce cost – in an putting more people on the payroll. • Continuous • Supply Chain becoming the most vital strategy to Lean Six Sigma is achieve ultimate organizational perfo Improvement • Logistics operational excellence. rmance and • QA/QC • Maintenance • Development • Accounting The 9th Lean Six Sigma for Pharmace utical, Biotech and Medical Device • Manufacturing • Packaging conference is back by popular dem Excellence and. Four key modules of case stud • Engineering • Information the newly developed 9th program: ies will be presented at • Innovation Technology • Reducing operational cost whil e improving efficiency • Continuous improvement: a foun dation for operational excellenc • • Speeding up R&D and improvin g technology Lean Six Sigma elevating organiza e Sponsorship & Exhibition tional performance Opportunities We would like to remind you that the 9th Lean Six Sigma for Pharmaceutica Sponsorships and exhibits are excellent opportunities for Medical Device Excellence Conferen l, Biotech and ce will be the only Pharma IQ gathering your company to showcase its products and services to continuous improvement, and oper for Lean Six Sigma, ational excellence professionals in 2010 highlevel, targeted decision-makers attending the 9th Lean to combine the West Coast conferen . We have decided ce into a larger East Coast gathering Six Sigma for Pharmaceutical, Biotech & Medical . We would like to encourage you to Device Excellence. IQPC and Six Sigma & Quality IQ help book your seat now and enjoy the companies like yours achieve important sales, marketing available! maximum discounts and branding objectives by setting aside a limited number Sincerely, of event sponsorships and exhibit spaces – all of which are tailored to assist your organization in creating a platform to and pay by maximize its exposure at the event. PS - Register to 09 and save up For more information on sponsoring or exhibiting at the 9th December 18, 20 m ww.lsspharma.co Lean Six Sigma for Pharmaceutical, Biotech & Medical Cathy Gu $2,345 (Visit w Device Excellence, please contact Mario Matulich at (212) Conference Director details.) 885-2719 or sponsorship@iqpc.com. www.lsspharma.com for full pricing Venue Information The Hyatt at Bellevue IQPC has a reduced-rate room block for participants of the 9th Lean Six Sigma for Pharmaceutical, Biotech, and Medical Device 200 South Broad Street Excellence Conference at The Hyatt at Bellevue. The group rate is available for 3 days pre- and post-conference, based on Philadelphia, PA 19102 availability. Please make your reservation before February 1, 2010 by calling (215) 893-1234. Be sure to mention you are (215) 893-1234 attending IQPC - LSS Pharma for the group rate when making your reservation. Registration Information TEAM DISCOUNTS: For information on team discounts, please contact IQPC Customer Service at 1-800-882-8684. Only one discount may be applied per registrant. Special Discounts Available: A limited number of discounts are available for the non- Standard profit sector, government organizations and academia. For more information, please contact Pricing Price customer service at 1-800-882-8684. Details for making payment via EFT or wire transfer: JPMorgan Chase Main Conference $1,799 Penton Learning Systems LLC dba IQPC: 957-097239 ABA/Routing #: 021000021 All Access Pass $2,799 (save $1,745) Reference: Please include the name of the attendee(s) and the event number: 10490.008 Workshops $549 each Payment Policy: Payment is due in full at the time of registration and includes lunches and refreshments. Your registration will not be confirmed until payment is received and may be subject to cancellation. For IQPC’s Cancellation, Postponement and Substitution Please note that multiple discounts cannot be combined. Policy, please visit www.iqpc.com/cancellation A $99 processing charge will be assessed to all registrations not accompanied by Special Dietary Needs: If you have a dietary restriction, please contact Customer Service at 1- credit card payment at the time of registration. 800-882-8684 to discuss your specific needs. MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC ©2010 IQPC. All Rights Reserved. The format, design, content and arrangement of this brochure constitute a trademark of IQPC. Unauthorized reproduction will be actionable * CT residents or people employed in the state of CT must add 6% sales tax. under the Lanham Act and common law principles. 2 1-800-882-8684 | www.lsspharma.com

Pre-Conference Workshops February 22, Monday A 8:00 am – 10:30 am Registration 7:45 (Coffee Served) Mastering DFSS to Create and Maximize Value for Your Business and Customers With more and more companies embracing the Six Sigma philosophies and tools, new How will you benefit: questions have arisen, especially from the areas where new processes are needed. • Learn the key principles and toolkits for DFSS DFSS has been identified as a vital strategy to create and maximize value for the • Streamline the DFSS design processes with a crystal-clear understanding of the organization’s performance and customer satisfaction. In this master class, we will toolkits walk you through the key principles and tools for DFSS to achieve maximum results. • Obtain the practical techniques to help you strategize and implement your DFSS project What will be Covered: • Understanding why we need DFSS and where DFSS processes can be applied Your Workshop Leader: • Elaborating the DFSS principles: Define – Measure – Analyze – Design – Verify Jeff Slutsky, Global Director of DFSS, Bausch&Lomb Inc. • Understanding the differences and similarities between DMADV and DMAIC • Demonstrating the DFSS value stream and value creation with specific case studies B 11:00 am – 1:30 pm Registration 10:45am (Lunch Served) Implementing and Managing a LSS Culture in Biopharmaceuticals: Brainstorming with LSS Experts from GSK No matter where you are in your Lean Six Sigma journey, addressing the needs of - How do you get over the fear of using and applying Six Sigma? the people to sustain a program or a project implementation is difficult. While some - How do you get the right people involved at the right time on the right initiative? of us are better than others, no one has completely mastered this arena, where there is always room for improvement. As a panel workshop, we will review the How will you benefit: various approaches, success stories, failure anecdotes, and reflect on how these • Join the panel discussion to participate in the journey of LSS culture management lessons can be applied to our own organizations. • Learn and experience the essential success factor for both products and LSS programs and how to stay in tune with the culture What will be covered: • Learn from experienced LSS experts and apply lessons to your organization • Demonstrating GSK timeline of starts/stops/restarts • Extensive case studies will be explored • Highlighting key programs, projects and initiatives Your Panel Workshop Leaders: • Open floor to others who have experience Lyndi Gillespie, Operational Excellence Expert, Global Manufacturing & Supply - How do you keep it going? Biopharm, GlaxoSmithKline - How do you get everyone (from top to bottom) involved? - How do you make sure that it's not just the full-time experts doing the work? Deepa Kumar, Operational Excellence Expert, Global Manufacturing & Supply - How do you continually engage the Advocates and GBs? Biopharm, GlaxoSmithKline - How do you integrate R&D with manufacturing? {How do you approach Kimberly Palladino, LSS MBB, Biopharm R&D, GlaxoSmithKline commercialization?} C 2:00 pm – 4:30 pm Registration 1:45 pm (Refreshment Served) Selecting, Designing and Managing Lean Six Sigma Projects Using Economic Valuation Six Sigma projects, just as any other project in a company, have economic value, • Managing a portfolio of projects to maximize value downside risk and upside potential. Such projects may have upfront investments, • Collecting the necessary data, build models and present results using Decision require some time before benefits can be achieved and often have technical risks. The Options Technology (DoT) value of a project is a function of these costs, timelines, risks and anticipated benefits. However, none of these can be determined in a precise fashion before the project can How will you benefit: be undertaken. All of these are uncertain, but they often provide flexibility to change • Create a systematic process for the identification and selection of competing course in the future. Decision Options is a holistic method to calculate economic projects and alternatives, yielding faster and better decisions value when uncertainties and decision flexibilities are present. Using economic value • Create a portfolio management process for Six Sigma projects for maximizing value and associated downside risk and upside potential, companies can make better and making dynamic decisions resulting in faster and better management and selection, design and management decisions of Six Sigma projects. The workshop will tracking focus on demonstrating these tools and techniques through case studies. • Implement a process for the evaluation of all alternatives - existing and new to assure consistency in all decision processes What will be covered: • Build consensus faster with an easy-to-understand and consistent set of tools and • Valuing Six Sigma projects, options and alternatives using decision options processes • Using economic value, downside risk and upside potential in making selection and design decisions Your Workshop Leaders: Gill Eapen CFA, Founder and Managing Principal, Decision Options, LLC Jennifer Miller, Executive Director, Pfizer D 5:00 pm – 7:30 pm Registration 4:45 pm (Dinner Served) What’s Next After Lean Six Sigma? Considerable progress has been made in the use of Lean Six Sigma to improve the • Process management systems that integrate process design, improvement and control performance of life science industries. Many are now asking what’s next and what • Holistic thinking that makes improvement a business process that is integral to can be done after implementing Lean Six Sigma? Just as business improvement how the business is operated approaches have grown and evolved over the last 100 years, so is Lean Six Sigma. This workshop addresses recent developments in the use of Lean Six Sigma and how How will you benefit: you can measure, evaluate, benchmark and update the approach used by your • Understand key methods that will help you lead your organization toward more organization. The session will be highly interactive, using a mixture of material effective improvement presentations, discussions and responses to participants’ questions. • Study ideas on how they can be more effective in their leading improvement initiatives What will be covered: • Learning from case studies that demonstrate the benefits of using a more holistic • Moving from project-by-project improvement to continuous improvement approach to improvement • Change management methods needed to sustain the deployment of Lean Six Sigma • Development of a project portfolio approach to identification and management of Your Workshop Leaders: improvement Ron Snee, President, Snee Associates, LLC. 3 1-800-882-8684 | www.lsspharma.com

Main Conference Day One February 23, Tuesday 8:00 Registration & Coffee Module 2: Continuous Improvement: a Foundation for Operational Excellence 8:45 Opening Remarks from the Chairperson 1:30 Keynote: Instilling Lean Six Sigma Culture to Module 1: Reducing Operational Achieve Operational Excellence Cost while Improving Efficiency • Lean Six Sigma is not a tool, but a culture • Getting the buy-in not only from top management, but also from 9:00 Keynote: Driving Down Operational Costs and the shop floor employees • Developing effective change-management strategies Ensuring Sustainability • Overcoming resistance during the Lean Six Sigma implementation • Identifying the role of Lean Six Sigma for modern pharmaceutical and biotech organizations Lori Lesko, Continuous Improvement, Pharmaceutical Sciences, • Understanding key considerations for the Lean Six Sigma program Pfizer • Measuring the Lean Six Sigma program performance to ensure sustainability 2:15 Business Process Kaizen Implementation and • Driving the value throughout the entire value chain Performance Improvement Bruce Sawyer, Senior Director, Global Business Excellence, GPSG, The organizations that have taken the approach to organize around Johnson & Johnson value streams (allow employees to recommend changes (Kaizen) to make a difference, and to demonstrate that they can be trusted) 9:45 Case Study: Prioritizing and Executing Lean are realizing the payback and are reaping major rewards both in Transformation Projects to Align with Business and employee performance and cost savings. • Empowering employees from the front line up with extensive Organizational Development Lean transformation program in Shire has met its two-year mark, training, coaching, Lean identification, continuous improvement and new challenges have emerged during the development. In this process, quick implementation, and reward and recognition • Developing a systematic process to fit the organizational structure session, Paul will be sharing the major challenges and Lean • Practicing value streams in various aspects including project transformation experience in this rapid development environment. • Prioritizing Lean transformation projects that have the greatest management, planning, purchasing, materials management, impact on the organizational strategies production, quality control, mechanics and engineers and warehouse • Dealing with the reactive projects and initiatives that commence • Using Kaizen throughout the entire organization, reinforcing the in different functional areas in a cost-efficient manner values and importance of each individual no matter where they • Gaining leadership agreement on the areas of focus are in the organization • Refining the process by dealing with the “chasing symptoms” Charles Aubrey, Vice President Performance Excellence, challenge Anderson Pharmaceutical Packaging • Fostering the root cause analysis culture and boosting Lean transformation results 3:00 Afternoon Refreshment & Networking Break Paul Nelson, Supply Chain Senior Director and Lean Transformation Leader, Shire Pharmaceuticals Inc. 3:30 Case Study: Learning How Merck Developed and Deployed a Continuous Improvement Strategy 10:30 Morning Refreshment & Networking Break • Developing the strategy and organizing the effort • Leveraging HPO and inclusive behaviors • Prioritizing the effort 11:00 A New Approach for How to Conduct a LSS Project: • Building the organization - setting the foundation The Double LEAN Method • Leveraging the lean and six sigma tool sets • Implementing LSS to make it work in your organization: Design of the Structure - Kaizen • Defining LSS to differentiate it from Six Sigma - Establishing the visual factory and governance system • Identifying the need for an alternative to DMAIC and DMAIC - Black Belt Projects barriers to project success - Scientific problem solving • Conducting an improvement project using Double LEAN • Execution to meet business needs Dr. Mark Gershon, SSMBB, President, World Class Training Gordon Jonas, Master Black Belt, Manager, Lean Six Sigma, Merck Institute 4:15 Panel Discussion – Lean Six Sigma Lessons Learned 11:45 Panel Discussion: Doing the Right Things and Doing • Brainstorming the major roadblocks during the Lean Six Sigma Them Right – Achieving Sustainable Improvement journey • Understanding the process owner’s perspectives on objectives and • Understanding the specific challenges in different Lean Six Sigma priorities phases • Examining the key challenges of achieving and sustaining • Considering all factors and elements that might be challenging: efficiency business strategy, toolkits and people • Eliminating costs – where are they and how to reduce them • Proposing practical suggestions to overcome these roadblocks and • Introducing the applications of TPM (total productivity challenges maintenance) Moderator: • Developing a performance measurement and ROI system to Bryan Winship, Managing Consultant, Tunnell Consulting evaluate and reinforce the results • Generating more bottom line, using Six Sigma to drive reliability Panelists: Bill Bolding, VP Operations and Process Improvement, Tunnell Panelists Include: Consulting Mario Roman, Operational Excellence Principal, Genentech Bruce Sawyer, Senior Director, Global Business Excellence, GPSG, Edward S. Kaercher, PMP, Facility and Project Management, PPD- Johnson & Johnson Vaccines and Biologics Gordon Jonas, Master Black Belt, Manager, Lean Six Sigma, Paul Casto, Vice President & SME on Work Process Optimization, Merck Meridium Inc. 5:00 Closing Remarks from Chairperson and End of 12:30 Networking Luncheon Day One 4 1-800-882-8684 | www.lsspharma.com

Mid-Conference Workshops E 5:30pm – 8:00pm Registration 5:15pm (Dinner will be served) Achieving Lab Excellence with Lean and Kaizen Implementations Over the past decade, many of the leading manufacturers of pharmaceuticals and How will you benefit: biologics have applied Lean principles to their manufacturing processes, resulting in • Learn how to implement Lab Excellence within your manufacturing or research labs dramatic improvements in cycle times, quality, and productivity. To realize the full • Understand how to utilize Lean to dramatically reduce release cycle time, increase benefits that Lean can offer however, requires applying the same principles in the productivity, and reduce deviations lab, resulting in dramatically reduced cycle times, improved lab capacity, and • Discover best practices and critical success factors streamlined process flows, all while increasing compliance. • Become exposed to real case studies and examples for how to utilize Lean in the lab What will be covered: About your workshop leader: • The Case for Action: Assess opportunities and develop a business case Thomas Bertels, Partner, Valeocon Management Consulting • Achieving quick wins through Kaizen: Reduce cycle time, eliminate non-value Thomas is responsible for Valeocon's practice in the United States and leading the added steps, streamline sample flow firm's life sciences practice. He is a widely recognized expert on Operational • Managing a Lean lab: Create a performance management system, establish a Excellence and has worked extensively with leading firms such as Pfizer, Novartis, visual workplace, define standard work J&J, and Lonza. • Designing a Lean Quality System: Leverage suppliers, streamline procedures, utilize PAT Main Conference Day Two February 24, Wednesday 8:00 Registration & Coffee 1:15 Designing the Future: Changing R&D Performance using Lean Sigma 8:45 Opening Remarks from the Chairperson • Understanding the opportunities and challenges of using Lean Kelly Canter, Ph.D., Global Research & Development, Pfizer Sigma in an R&D environment • Using Value Stream thinking to drive performance improvement • Building momentum to simplify and align Continuous Module 3: Speeding Up R&D and Improving Technology Transfer Improvement in R&D Keith Russell, Global Lean Sigma Director, AstraZeneca 9:00 Unlocking the Power of Innovation and TRIZ in your Organization Module 4: Lean Six Sigma Elevating • Learning how innovation has emerged as a key to improved problem Organizational Performance solving, planning and product development • Understanding the hierarchy of innovation/TRIZ approaches 2:00 Roundtable Discussions – Choose Your Table of • Analyzing the similarities and differences between the various TRIZ Discussion and Walk Away with Great Suggestions schools and approaches and Experiences from Your Peers • Demonstrating guidelines to select the right innovation tools based on the task and the innovation experiences of the team members A •Lean Six Sigma in Manufacturing: Identifying the key challenges of implementing Lean Six Sigma on the shop floor Bob King, CEO and Founder, GOAL/QPC Discussion Leader: Charles Aubrey, Vice President Performance Excellence, Anderson Pharmaceutical Packaging 9:45 Implementing and Experimenting QbD and DFSS Tools to Accelerate R&D and Improve Technology Transfer B •Lean Six Sigma in R&D: Engaging scientists into the Lean • Understanding the principles of QbD Six Sigma projects to streamline the R&D process • Implementing QbD into the R&D process Discussion Leader: Kelly Canter, Ph.D., Global Research & • Integrating the key elements of DFSS Development, Pfizer • Experimental planning on the science scale tool to improve technology transfer C •Lean Six Sigma in Transactional Business: Achieving commercial and business excellence by applying Lean Six Kelly Canter, Ph.D., Global Research & Development, Pfizer Sigma methodologies in all the processes beyond shop floor 10:30 Morning Refreshment & Networking Break Discussion Leader: Erik Lissner, Senior Associate, Valeocon Management Consulting 11:00 Implementing a Culture of Quality by Design • Developing a QbD training strategy for drug development teams 2:45 Afternoon Refreshment & Networking Break • Leveraging industry case studies for interactive training • Implementing QbD in solid dosage and biologics applications 3:15 Keynote: Developing a Practical and Effective Kevin D Cluff, Ph.D., P.E., Business Excellence MBB, Drug Measurement Process with Lean Six Sigma Approaches Development MBB, Drug Product Development, Global Pharmaceutical to Improve the Organizational Performance R&D, Abbott Laboratories • Introducing Lean Six Sigma approaches into the performance measurement process 11:45 Panel Discussion: Innovating your R&D Process • Building a business case for Lean Six Sigma deployment in • Answering the questions regarding DFSS and QbD implementation transactional areas • Selecting the most appropriate approach that aligns with your R&D • Case study from Genentech process and culture Mario Roman, Operational Excellence Principal, Genentech • Suggesting practical ideas to get scientists involved • Improving technology transfer with Lean Six Sigma methodologies 4:00 Case Study: Leveraging Lean Six Sigma to Improve • Optimizing R&D process and speed up time-to-market the Transaction Process of Medical Device Records Panelists Include: Submission • Understanding key challenges and project goals to prepare for Kevin D Cluff, Ph.D., P.E., Business Excellence MBB, Drug project implementation Development MBB, Drug Product Development, Global Pharmaceutical • Mapping out the medical device records submission value stream R&D, Abbott Laboratories • Evaluating and redesigning the transaction processes to eliminate Kelly Canter, Ph.D., Global Research & Development, Pfizer waste and improve efficiency • Sharing the project results with Lean Six Sigma in place 12:30 Networking Luncheon Renee Cveykus, Senior Medical Device Records (MDR) Vigilance Manager – Cardiac Rhythm Disease Management (CRDM), Medtronic ENT 4:45 Closing Remarks from Chairperson and End of 5 1-800-882-8684 | www.lsspharma.com Conference

International Quality & Productivity Center ❑Yes! Please Register Me For 535 5th Avenue, 8th Floor New York, NY 10017 9th Lean for Pharmaceutical, Biotech, Six Sigma and Medical Device Excellence ❑ Conference only ❑ Workshop(s) ❑ All Access Pass Please Choose Workshop(s): ❑A ❑B ❑C ❑D ❑E Your customer registration code is: When registering, please provide the code above. Name__________________________________ Job Title ________________________ Organization____________________________________________________________ Approving Manager______________________________________________________ Address_______________________________________________________________ City__________________________________State______________Zip___________ Phone________________________________Fax_______________________________ E-mail__________________________________________________________________ 5 EASY WAYS TO REGISTER: ❑ Please keep me informed via email about this and other related events. 1 Web: www.lsspharma.com ❑ Check enclosed for $_________ (Payable to IQPC) 2 Call: 1-800-882-8684 ❑ Charge my __Amex __Visa __Mastercard __Diners Club 3 Email: info@iqpc.com Card #__________________________________Exp. Date___/___CVM code______ 4 Fax: 1-646-378-6025 Details for making payment via EFT or wire transfer can be found on 5 Mail: IQPC preceding page. 535 5th Avenue, 8th Floor ❑ I cannot attend, but please keep me informed of all future events. 10490.008/D/NW New York, NY 10017 Take advantage of the All Access Package and SAVE up to $1,745 (see page 2 for 9th Lean details) Six Sigma Improving Organizational for Pharmaceutical, Performance While Reducing Operational Costs Biotech, and Medical February 22-24, 2010 Device Excellence The Hyatt at Bellevue Philadelphia, PA Sponsors: Media Partners: CanBiotech R&D Outsourcing Capital Sourcing Competitive Intelligence

"Lean Six Sigma & Process Improvement for Customer Experience

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