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February 21-23, 2012 | Atlanta, GA TOP REASONS TO ATTEND: Create your own personalized conference agenda by selecting among our featured plenary & breakout session topics: • Culture & Management Buy-in • Lean & Six Sigma Trends • Research & Development (R&D) • Lean Innovation • Regulatory Compliance • Capital Improvements • Strategic Supplier Partnerships • Employee Engagement • Mature Programs/ Projects • Mergers/Acquisitions • Knowledge & Change Management • Optimized LSS Project Portfolio • Supplier Integration • Sales & Marketing • Lean A3 Problem Solving Method • Manufacturing • Silos • Benchtop Equipment Selection • Regulated QC Laboratory • Lean Laboratory • Packaging • TPS Pillar of Jidoka www.LSSPharma.com Advancing Continuous Improvement and Innovation within Your Organization is pleased to announce the Follow our expert speakers on: 1-800-882-8684 | [email protected]| www.LSSPharma.com Register by 12/16/11 to receive the lowest available price! See page 8 13th Annual for Pharmaceutical, Biotech, and Medical Device Excellence Lean Six Sigma Media Partners: Sponsor: Hillary M. Wilson Business Operations Lead, Pradaxa Marketing Boehringer Ingelheim Pharmaceuticals, Inc. Terence Barnhart Senior Director Pfizer Worldwide R&D Paul Nelson Supply Chain Senior Director & Lean Sigma Leader Shire Pharmaceuticals Inc. Charles Aubrey Vice President of Quality and Lean Six Sigma Anderson Pharmaceutical Packaging Deepa Kumar Operational Excellence Expert GlaxoSmithKline Diane Francisco Director of Process Excellence, Global Commercial Organization Covance David Haigh, Sr. Process Excellence Manager Johnson & Johnson Inc. (Canada) Michael McSweeney Senior Operational Excellence – LSS Master Black Belt GlaxoSmithKline Lyndi Cole Operational Excellence Expert GlaxoSmithKline Brian Eden Senior Director and Global Head, Operational Excellence Mylan Pharmaceuticals Winston Brown Director, Global Quality Compliance Baxter HealthCare Corporation William Favier Director, Lean Sigma Training Bristol-Myers Squibb Co. Nick Ruhmann Continuous Improvement Leader, Master Black Belt BD Medical - Diabetes Care Kelly Kujan Vice President of Continuous Improvement Fenwal Inc. AND MANY MORE. . . . Learn case studies & best practices from these leading industry experts: NEW FOR 2012: Breakout Sessions Personalize Your Agenda
Transcript
February 21-23, 2012 | Atlanta, GA
TOP REASONS TO ATTEND: Create your own personalized conference agenda by selecting among our featured plenary & breakout session topics:
•Culture & Management Buy-in
•Lean & Six Sigma Trends
•Research & Development (R&D)
•Lean Innovation
•Regulatory Compliance
•Capital Improvements
• Strategic Supplier Partnerships
•Employee Engagement
•Mature Programs/ Projects
•Mergers/Acquisitions
•Knowledge & Change Management
•Optimized LSS Project Portfolio
• Supplier Integration
• Sales & Marketing
•Lean A3 Problem Solving Method
•Manufacturing
• Silos
•Benchtop Equipment Selection
•Regulated QC Laboratory
•Lean Laboratory
•Packaging
•TPS Pillar of Jidoka
www.LSSPharma.com
Advancing Continuous Improvement and Innovation within Your Organization
for Pharmaceutical, Biotech, and Medical Device Excellence
Lean Six Sigma
Dear Colleague,
IQPC is proud to present the 13th Lean Six Sigma for Pharmaceutical, Biotech and Medical Device ExcellenceConference.ForthefirsttimeontheEastCoastthiseventwillfeaturebreakout sessions designed to provide additional content for delegates to choose from.
Personalize your conference agenda and tackle your biggest hurdles and areas of interest. You will hear over 28+ in-depth case studies and workshops bringing you innovative solutions addressing top industry concerns including:
• Analyzing the latest and upcoming trends in this industry • Deploying LSS in a regulated business• Utilizing lean six sigma throughout your entire organization - beyond manufacturing• Selecting and resourcing the optimized LSS project portfolio • Building vendor partnerships & becoming strategic with your suppliers • Achieving sustainability and success through knowledge & change management• Fostering a culture of continuous improvement and understanding the value of employee engagement• Opportunities in the regulated QC laboratory • Applying the Lean A3 problem solving method• Addressing the next steps for mature six sigma & lean projects/programs• Implementing lean innovation: aframeworktoimproveefficiency&effectivenessof the innovation process
Additionally, this event offers interactive networking opportunities and sessions. This is your opportunitytosharespecificchallengesaffectingyourorganization,exchangecontactinformationand 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 benchmark against developing and proven strategies.
Sincerely,
Claudia RubinoProgram Director Six Sigma & Process Excellence IQ, division of IQPC [email protected]
SPONSORSHIP & EXHIBITION OPPORTUNITIESEvent sponsorship is an excellent opportunity for your company to showcase its products andservices to high-level, targeted decision makers attending the 13th Lean Six Sigma for Pharmaceutical, Biotech & Medical Device Excellence Conference. IQPC and Six Sigma & Process Excellence IQ help companies like yours achieve important sales, marketing, and branding objectives by setting aside a limited number of event sponsorships – all of which are tailored to assist your organization in creating a platform to maximize its exposure at the event. For more information on sponsoring at this or upcoming events, please contact Kimberly Sun at (212) 885-2662 or [email protected].
Attend the MUST SEE pre-conference workshops designed to
address challenges and
come up with immediate
actionable solutions! See page 3.
P.S.
WHO WILL YOU NETWORK WITH?Champions, Master Black Belts, Black, Green, Belts Executive/ Senior Vice Presidents, Vice Presidents, Directors, Project Coordinator, Managers, Heads and leaders of:
• Lean Six Sigma• Process Excellence• Operational Excellence• Business Excellence• Continuous Improvement• Knowledge & Change Management• Strategy Management• QA/QC• Research & Development • Clinical Trials• Sales & Marketing• Manufacturing• Engineering• Innovation• Validation• Regulatory Compliance• Information Technology• Supply Chain• Logistics• Supplier Quality• Accounting/Finance• Packaging• Laboratory
About the organizer:Six Sigma IQ, a division of IQPC, provides usefultraining courses, conference and expositions forpharmaceutical executives to network and learnthe latest pharma business development andtrends occurring in organizations today.
Pre – Conference WorkshopsTuesday, February 21, 2012
Our series of workshops have been designed to translate winning strategies from leading experts and develop them intotangiblebenefitsyoucantakeawayandimplementwithinyourowncompany’sprocedures.Jointhe
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 project. While this works on the project level, it does not lead to a successful program of Process Improvement within the company. The portfolio of projects needs to be viewed as a whole, and individual projects added to it in a way that links with company strategic goals. Also, the resources may not be in place and available to successfully complete all projects, or there may be overlap between projects that create problems. For the Process Improvement program to be successful, project selection must be done as part of Portfolio Management. Developing the optimal portfolio is the goal of this workshop:
What will be covered: • How to evaluate single projects • How to link individual project goals to company goals • How to identify inter-dependencies between projects • How to detail the resource needs of a project
• How to aggregate resources required for the portfolio • How to select the portfolio that maximizes attainment of company goals • How to ensure that the resources are in place to carry out the portfolio of projects
How you will benefit: • Maximize the odds that your projects achieve their goals • Reduce frustration among overworked team resources • Be able to see the big picture of what your Process Improvement program is doing • Maximize the value of the portfolio of projects to the company
Your Workshop Leader:Dr. Mark Gershon, SSMBB, President, World Class Training Institute
B 11:00pm -1:30pm 10:45am Registration for Workshop B (Boxed Lunches will be Served)LEAN A3 PROBLEM SOLVING METHOD
Much more than just a tool, A3 Problem Solving is a simple method to systematically helpdefineandsolveproblems.Thisworkshopwillexploreawayofthinkingthatcausesentire teams of people to sharply focus their minds on the foundational Lean ways ofseeingprocessflowsandwastes,constantlyredirectingtheirattentionbacktothefoundational lean teachings:
What will be covered: • Simple and consistent way to achieve and document root cause analysis • Create the target condition
• An intuitive and easy way to learn and remember
How you will benefit: • Improveyourabilitytodefineandsolveproblems • Teach managers how to better coach, mentor, and lead • The A3 method offers a long-missing standardized approach to solving problemsidentifiedinhigher-levelvaluestreammaps
Your Workshop Leaders:Terence Barnhart, Senior Director, Pfizer Worldwide R&D
D 4:30pm – 6:30pm 4:15pm Registration for Workshop DLEAN INNOVATION: A FRAMEWORK TO IMPROVE EFFICIENCY & EFFECTIVENESS OF THE INNOVATION PROCESS
Most Lean implementations have been used to reduce waste in operations. Deploying Lean has led to cost savings and excess capacity in equipment and human resources. Leadershipandstakeholdersexpectfinancialreturns.UtilizingLeanaggressivelyforreducing waste has also resulted in ignorance of the need for business growth requiring innovation.HenceLeanwithoutinnovationwouldresultinprofitinashrinkingbusiness.This scenario does not appear a viable solution for businesses in the long. Operational performance accounts for about 10% of the corporate performance. In order to maximizebenefitsofLeanSixSigma,corporationsmustfocusonbusinessdevelopmentby introducing new products or services. Lean Innovation is a framework that improves efficiencyandeffectivenessoftheinnovationprocessbasedonbestpracticesofgreatinnovators. Lean Innovation framework reduces waste in the innovation process for accelerating innovation and increasing return on investment in innovation. This way additional capacity is utilized for realizing business growth instead of downsizing businesses. This workshop will assess their Lean Six Sigma initiatives and corporate performance, use ideation process in lean deployment, and practice creativity:
What will be covered: • Learn the innovation framework consisting of fundamental business strategy • Incentives for inspiration, rules of creativity and types of thinking • Analysis of the phases of an innovation methodology
How you will benefit: • UtilizeTEDOCmethodologyforinnovativedeploymentofleanforbetter outcomes and for developing new products or solutions for revenue growth • Take away a better understanding of Lean Six Sigma Assessment Tool • Discover a simple yet powerful creativity process • Make use of lean innovation methodology and innovative ideas for current project(s) at work in your organization
Your Workshop Leader:Praveen Gupta, President, Accelper Consulting
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 Steven Spear and how it was incorporated by Toyota into their supplier training in regard to the lack of understanding of the Jidoka Pillar by western companies. Analyze how a focus on the visible aspects of Toyota have created a gap in the understanding of Lean and resulted in the stagnation of many companies Lean journey.
What will be covered: • Error prone vs. high performance systems • Capabilities of the operational outstanding • True north (ideal state) • TheFOURlevelsofprocessdesign
How you will benefit: • Gain a better understanding of the Jidoka Pillar, and how ignoring it causes stagnation in the ability to be “Just in Time” • Understandthecapabilitiesweasleadersshouldbepropagatinginallemployees • Actual Gemba Kaizen - apply the principles on our host location before leaving!
Your Workshop Leader:Nick Ruhmann, Continuous Improvement Leader, Master Black Belt, BD Medical – Diabetes Care
MAIN CONFERENCE DAY 1 Wednesday, February 22, 20128:00 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 DEVELOPMENTSThepharmaceutical,biotech&medicaldeviceindustrieshaveseentheinitialbenefitsofimplementingsixsigma&leanprocessesandtechniquesintotheireverydayoperations.Withmanyoftheseprogramsfinallyseeingsomeinitialbenefitsanddrawbacksandasthestoriesofsuccessesandfailurescontinueto 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 projectsPanelists: 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 inlightofthechangingenvironment,givespecificexamplesofhowsomebasicLeanSigmatoolsandapproachescanbetweakedandadjustedtospeedupthe process and discuss how the “democratization of learning” can be leveraged to make organizations more responsive. Here you will:• Understandtodaysbusinessanditsfastpacedenvironment• Learn a step by step approach to improving your current operations• Determine the best tools and approaches to increase the speed of your operationSpeaker:William Favier, Director, Lean Sigma Training, Bristol-Myers Squibb Co. JohnGhidiu,CertifiedSixSigmaBlackBelt(ASQ),CertifiedPerformanceTechnologist(ISPI),CertifiedProfessionalinLearningandPerformance(ASTD)
10:30 MORNING NETWORKING AND REFRESHMENT – CARD EXCHANGE
11:15
12:00
CASE STUDY: APPLYING INNOVATION TO PHARMACEUTICAL PACKAGING: BETTER PATIENT OUTCOMESInnovation is the key to success for any business. Determining the best way to apply this concept within your operations and procedures will be an essential and crucial step to continuous improvement. Join us in analyzing Anderson Pharmaceutical Packaging’s development, implementation and assessment of their innovation initiative within their packaging department, andanalyzingthekeysbenefitsandlessonslearnedthroughouttheirjourney. This case study will:• Review the various innovation methods: Design for Six Sigma, Blue Ocean and TRIZ• Discuss the process to convert innovations to patents• Demonstrate how patented products can be commercialized • Show how the develop investment and commercialized innovationsrealizesignificantpayback• Prove how the innovations provide better health outcomes for patientsSpeaker:Charles Aubrey, Vice President, Anderson Pharmaceutical Packaging
CASE STUDY: MEASUREMENT SYSTEM ANALYSIS (MSA) FOR BENCHTOP EQUIPMENT SELECTIONThis is a case study based on a project that allowed the GSK Biopharmaceutical manufacturing group to choose benchtop equipment (such as those used to assay in-process test samples) to better suit the needs warranted by the drug substance manufacturing process. In the past such decisions were not always made using a statistically driven approach. You will learn to:
CASE STUDY: DEPLOYING LEAN SIX SIGMA IN A SALES AND MARKETING ORGANIZATION Implementation of Lean Six Sigma (LSS) in contract service companies would not be considered to be novel or new these days. Service companies have embraced this structured approach for continuous improvement of their key operational processes. They have shown success in reducing cycle time, improving quality and creating value for their customers and businesses. With all of this success, one might assume that LSS would be practiced in all areas of the organization. This assumption however would be false. Sales and Marketing were areas that LSS was believed to not be applicable. It is only recently that deployment of LSS in Sales and Marketing groups has been seen as a value add. Key points that will be discussed include:• Get your foot in the door: Put process excellence and improvement in front of mind for management in all strategy • Develop a deployment roadmap or plan that meets the needs of the Sales and Marketing groups, while taking in to consideration the group cultures• Achieve organizational alignment between leadership targets and improvement goals for maximum project impact• Developaflexible,yetstandard,frameworkforscoping,prioritizingand executing improvement projects Speaker: Diane Francisco, Director of Process Excellence, Global Commercial Organization, Covance
CASE STUDY: BEST PRACTICE – ASSESSING OPERATIONAL IMPROVEMENT OPPORTUNITIES FOR PHARMACEUTICAL SALES & MARKETING TEAMS This presentation will review methods for assessing productivity improvement opportunities in sales and marketing. The presentation focusesondesigningtheassessmentapproach,assessingbenefitandeffort,and gaining key stakeholder alignment. Attendees will receive a long list of potential places to look within their organizations to identify.
MAIN CONFERENCE DAY 1 Wednesday, February 22, 2012
• UseoftheDMAICmethodologywithacrossfunctionalteamto understand process / customer requirements for the assay in question• Design appropriate Measurement Systems Analysis experiments involving equipment/instruments, analysts, number or samples, replicates, etc. to obtain enough data to be studied• Employ statistics to understand variability of each piece of equipment for the manufacturing process• Implement a weighted matrix approach using the statistical data to make decisions on equipment selectionSpeaker:Deepa Kumar, Operational Excellence Expert, GlaxoSmithKlineLyndi Cole, Operational Excellence Expert, GlaxoSmithKline
• Gotta take 10% out of your budget and still do all the same work: Address this situation at your company• Marketing stakeholder management in an environment that is resistant to change• Pharma marketing agencies – setting new expectations of productivitySpeaker:Hillary M. Wilson, Business Operations Lead, Pradaxa Marketing, Boehringer Ingelheim Pharmaceuticals, Inc.
2:30 CASE STUDY: OPPORTUNITIES FOR LEAN SIX SIGMA IN THE REGULATED QC LABORATORYOnce the primary domain of manufacturing operations, Lean Six Sigma approaches are now penetrating analytical quality testing laboratories and Quality Assurance (QA) organizations. As economic imperatives coupled with cultural shifts and technological advancements prevail over the historical aversion to change in these regulated environments, more Lean Six Sigma projects are moving from the perimeter of laboratory operations deeperintoQCworkflows.Thiscasestudywill:• Ensure data is captured completely and correctly to support regulatory compliance• Useintegratedlaboratoryinformaticssystemsfortraceabilityof batch record information, laboratory assets, analytical testing data, reports, etc. • Highlighttheincorporationofprocedure-basedworkflowsinto laboratory execution systems (LES)Speaker:Cozette Cuppett, Senior Informatics Marketing Manager, Americas, Waters Corporation
CASE STUDY: ACHIEVE RESULTS THROUGH BUSINESS PROCESSES & CORPORATE FUNCTIONSIntegrating Lean Six Sigma throughout an organization’s core business operationstoachieveearlybenefitsandfullself-sustainabilitynecessitatesa strong focus on core business processes and corporate functions. In this session, you will learn real examples on how to use Lean and Six Sigma to create agile business processes and to ensure your organization’s survival is this through economic and competitive environment. This case study will teach you to:• Assess both internal and external business processes • Analyze successful practices to streamline business processes & corporate functions• Addresscommondifficultiesanddrawbacks• Develop a step by step approach towards effecting change• ExplorecommondifficultiesanddrawbacksSpeaker:Terence Barnhart, Senior Director, Pfizer Worldwide R&D
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, continuousimprovementprogramsexperienceadropoffinbenefitor“hitthewall”onceamanufacturingsiteordistributioncenterhasoptimizeditscoreprocesses. 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• UnderstandwhatwillberequiredfromyourLeadershiptosupportthechange• Gain 3-4 practical ideas that you can immediately apply to your situationWilliam Owad, SVP, Operational Excellence, Cardinal Health
4:45 BUILD VENDOR PARTNERSHIPS AND BECOME STRATEGIC WITH YOUR SUPPLIERSDeveloping 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”)• FutureStateVSMidentifiescontinuousimprovementsprojects• Both you and vendor focused on same projects • Develop visual controls and metrics • Quality assurance reduced testing project• Risksidentifiedandassessed(singlesource,specialtyitems,longleadtimes,andetc)• 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. Take advantage of this opportunity to expand your network and gain quality contacts within you field. P.S. Please bring your business cards!!!
5:50 END OF MAIN CONFERENCE DAY 1
12:45 NETWORKINGLUNCHEON
1:45 CASE STUDY: ENSURE VALIDATION THROUGHOUT YOUR PRODUCT LIFECYCLEWith 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 productivitySpeaker:Winston Brown, Director, Global Quality Compliance, Baxter HealthCare Corporation
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 designedforspeakers,delegatesandserviceprovidersalike.Thegoalofthissessionistosharespecificculturalchallengesandideasandlearn from one another. •Determine the keys to establishing effective culture changes•Market stakeholder management in an environment that is resistant to changePanelists: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 increaseboththequalityandquantityoftheideassubmittedwithminimalinvestment.Understandtheimportantdifferencebetweena“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 • Tousekaizen’sasacoaching/mentoringopportunitytoincreasemanagement/shopfloorcooperation.Speaker:Nick Ruhmann, Continuous Improvement Leader, Master Black Belt, BD Medical - Diabetes CareGert 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 EXCELLENCEJoin 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?•Whatgapsneedtobefilled–Shortterm?Longterm?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 continuousimprovementapplication.Highlyregulatedindustriessuchasfoodandpharmaceuticalshavespecificconsiderationsinthisregard. 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
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 departmentsSpeaker:Nick Ruhmann, Continuous Improvement Leader, Master Black Belt, BD Medical - Diabetes CareBrian 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 whenfacingthedauntingtaskofmergingtwoorganizationsintoonestreamlinedefficientoperatingmachine.Youwilllearnto:•Assess current processes, strategies and goals for both organizations•Accelerate through the use of tools integrated through this strategic partnership•Understandthepitfallsandcomplicationresultingfromalargescalemerger•Align both organization’s goals and processesSpeaker: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
Thispresentationwillcoveraseriesofcasestudies,describingrecentsuccessesatJohnson&Johnsonaffiliatestoimprovetheircustomer-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, necessaryininfluenceactivities.Participantswilltakeawaythesetangibleactions:•Usetheframeworkofjointcustomervaluecreationtofindopportunitiesanddrivecustomerinvolvement• 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• Influenceinternalandexternalprocesses,includingthoseownedbyyourcustomer•Think through customer and employee impact when designing business and IT controlsSpeaker: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 andserviceprovidersalike.Thegoalofthissessionistosharespecificculturalchallengesandideasandlearnfromoneanother.•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®LaboratoryInformaticsisasoftwaresolutionforscientificdatamanagement, 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.
is pleased to announce the
Join our global online communityand download exciting new webinars andpodcasts developed by industry leaders for IQPC.
Register by 12/16/11 to receive the lowest available price!See page below.13th Annual
for Pharmaceutical, Biotech, and Medical Device Excellence
q I cannot attend, but please keep me informed of all future events.
February 21-23, 2012 | Atlanta, GA
MAKE CHECKS PAYABLE TO: IQPCA $99 processing charge will be assessed to all registrations not accompanied by credit card payment at the time of registration. *CT residents or people employed in the state of CT must add 6% sales tax.
Details for making payment via EFT or wire transfer:JPMorgan ChasePenton Learning Systems LLC dba IQPC: 957-097239ABA/Routing #: 021000021Reference: Please include the name of the attendee(s) and the eventnumber: 10490.012
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 Policy, please visit www.iqpc.com/cancellation
Special Dietary Needs: If you have a dietary restriction, please contact Customer Service at 1-800-882-8684 to discuss your specific needs.
All-Access Pass includes the 2 day main conference and all workshops. Please note multiple discounts cannot be combined. A $99 processing charge will be assessed to all registrations not accompanied by credit card payment at the time of registration. Call for team discounts.
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.
A vendor qualifies as equipment, technology or service providers to the pharmaceutical industry, biotech, and medical device industry.
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 as the information becomes available please email [email protected] with the following in the subject line: LSS Pharma Venue Request.
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