From maintenance to reliability ‒ Holistic and sopHisticated ...

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From maintenance to reliability ‒ Holistic and sopHisticated approacHes & solutions

5th – 6th November 2012 | MaRITIM pRoaRTe hoTel beRlIn

MoRe Than 15 case sTudIes | IcebReakeR sessIon | challenge youR peeRs | WoRld cafÉ sessIon

http://pharma-maiNteNaNce.we-coNect.com

pharma m2r miNds 20125Th – 6Th noveMbeR 2012 | MaRITIM pRoaRTe hoTel beRlIn



overviewpharma m2r miNds 2012

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lewis h. sita, director, gpo engineering / global headMaintenance excellence program (Mep)abbott laboratories / usa

Jean-pol gossuin, vice president, head of engineering &Technology Techopsmerck serono / switzerland

Robert christman, global Reliability coordinatorscott Morris, associate director of programsGenzyme / a sanofi company / usa

cormac ahern, site operational excellence leadpfizer / ireland

Michael Teasdale, senior director operation excellencebaxter bioscience / usa

Thomas gosmann, global process Teamlead, center of excellencebayer Healthcare aG, organization & information / Germany

giuseppe Mirra, director Reliabilty & Maintenance operationssanofi pasteur / usa

dr. christian Jurisch, head of Technical services pharmaJohnson & Johnson / switzerland

oliver kärst, head of Technical servicesWarner chilcott deutschland GmbH / Germany

Reinhold Maeck, director center of competence and projectsboehringer ingelheim pharma GmbH / Germany

dr. Mike battrum, head of engineeringaesica pharmaceuticals / uK

hans-peter vogels, ph.d., director Quality assurance / Qualified Personmeda manufacturing GmbH / Germany

nils blechschmidt, senior partner and head of the competence center Maintenance excellence & asset Innovationdr. Marc a. heinisch, senior partnerconmoto consulting Group GmbH / Germany

nick crosby, global Reliability and Integrity Managerbayer cropscience lp / usa

Tomislav Turk, Maintenance Manager assistantbelupo pharmaceutical and cosmetics / croatia

dr. ernst keck, head of asset strategy and business processes - doZroche diagnostics GmbH / Germany

francisco Ruiz, head of process engineering and Manufacturing Maintenanceboehringer ingelheim s.a. / spain

laurence plant, MIMeche principal consultantMartin brown, MIMeche principal consultantabb / uK

Mike gehloff, strategic account directorGpallied / uK

paul ludorf, head of Technical departmentrottapharm / ireland

frank hirsch, Manager support center & finishing operationsabbott GmbH & co KG / Germany

fabrice brion, I-care directori-care sprl / belgium

conor Troy, ownerconor troy & partner consultancy / switzerland

> RcM – Reliability centred maintenance & fMea – failure mode & effects analysis

> performing end-to-end root cause analysis using sap – how to make the most of root

cause analysis to progressively eliminate failures> asset performance Management (apM) is an

approach to managing the optimal deployment of assets to maximize profitability and

predictability in product supply> sap eaM & oee> Right first Time, continuous Improvement and

value stream mapping in maintenance activities, risks and challenges at a global & local level

> Integrated approach to budgeting, maintenance strategy optimisation and resource forecasting

> cost control strategies in maintenance: effective planning and engineering of new plants, (pilot

plants) design of plants, spare parts management and supplier relationship management in a validated environment

> challenges in human error prevention in pharmaceutical engineering & global workforce management

> preparation and conduct of inspections and audits and embedding of processes in an overall

maintenance strategy> asset care excellence (ace ) – Improving asset

performance and asset lifecycle management with world-class TpM

> predictive Maintenance – condition Monitoring, Communications, Efficiency, Diagnostics

> Calibration, re-qualification and synchronized maintenance of equipment

speaKers main topics

business partners




aGeNdaicebreaKer sessioN | sunday, 4Th noveMbeR 2012

20.00 | Round Tablepre-conference drinks and icebreaker round tables with speakers, business partners & participants

IcebReakeR Round Table 1implementing predictive maintenance strategies GloballyFabrice brion, I-care director, i-care sprl / belgium

IcebReakeR Round Table 2reliability centered maintenance and its contribution to equipment effectiveness and reduced maintenance cost dr. marc a. Heinisch, senior partner, conmoto consulting Group GmbH / Germany

we.coNect icebreaKerour Icebreaker session consists of small round tables with speakers, business partners and attendees where the audience will discuss the main challenges and cutting edgetopics of the conference in a relaxed atmosphere. glass in hand, make your way around our round tables and get to know each other. enjoy food and drinks at the opening of the conference, break the ice and get the show on the road.

contents

p. 2 | overview speakers Main Topics

p. 3 | icebreaker Icebreaker session business partners Media partners

p. 4-6 | conference day 1 challenge your peers evening session

p. 6-7 | conference day 2 Morning session World café

we.conect business peersTake advantage of solution-oriented individual meetings that we can arrange with these partners before and during the conference.

business partners

media partners

abb consultingdaresbury park business centre, daresbury, Warrington | Wa4 4bT cheshire, ukphone: +44 (0)1925 741111 | fax: +44 (0)1925 741212www.abb.com/consulting

con moto consulting Group GmbHboschetsrieder str. 69 | 81379 München, germanyphone: +49 (0)89 780 66 - 0 | fax: +49 (0)89 780 66 - 100 / -101email: [email protected] | www.conmoto-consulting.com

Gpalliedguldensporenpark 21, building c | be-9820 Merelbeke, belgiumphone: +32 (0)9 210 17 20 | fax: +32 (0)9 210 17 28www.gpallied.com | http://ireliability.com

i-care sprlRue descartes, 1/3 | b-7000 Mons, belgiumphone: +32 (0)65 45 72 14 | fax: +32 (0)65 84 55 35email: infoicareweb.com | www.icareweb.com

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aGeNdacoNfereNce day 1 | Monday, 5Th noveMbeR 2012

8.00 | Registration with coffee and tea

8.30 | Welcome and introduction by we.conecT and the chair chair: conor troy, owner, conor troy & partner consultancy / switzerland

we.coNect strateGy tracKmaintenance in the pharmaceutical industry – specific characteristics – specific demands8.40 | case studyreliability and a manufacturing operating system, a holistic approach to manufacturing excellence> Reliability is a key goal for any Manufacturing operating system> What is a Manufacturing operating system?> several strategies are key to driving better reliability in the large molecule pharmaceutical business > lean – 5s and maintenance > Integrated operations team and shared, key metrics: uptime, MTTR, MTbf, throughput > daily management meetings to ensure maintenance and manufacturing have common priorities > Risk assessment and mistake proofing > process analytic Technologymichael teasdale, senior director operation excellence, baxter bioscience / usa

9.20 | case studydevelopment of the Global mep (maintenance excellence program) of abbott – design, roll out, results & outcomes and integration into opeX in a transition phaselewis H. sita, director, gpo engineering / global head Maintenance excellence program (Mep),abbott laboratories / usa

we.coNect process tracK (1)process optimization in the pharmaceutical industry – success indicators and businessenablers for engineers and maintenance responsibilities10.00 | case studyreliability centered maintenance – root cause analysis, Failure modes & effects and criticality analysis for maintenance and reliability improvementlaurence plant, MIMeche principal consultant, abb / uKmartin brown, MIMeche principal consultant, abb / uK

10.40 | Refreshment break with networking Zone

11.00 | case studylocal roll out of a reliability centered maintenance program that puts front line personnel at the heart of the improvement process> developing a road map to world class maintenance that integrates continuous Improvement (cI) methodologies such as TpM, RcM, lean and 6 sigma> Integrating > Working in partnership with other departments to adopt a bottom-up approach in the deployment of cI methodologies> Rapidly deploying paperless cMMs and oee systems in the regulated environment to provide real time and accurate performance data to support improvement teams> case study results: failure rate reduction of 72%, planned worked increased from 20% to 75% and maintenance cost per pack has decreased by 64%paul ludorf, head Technical department, rottapharm / ireland

11.40 | case studylessons learned from the Front lines of an operator care program> a sharing of Real-World examples and lessons learned While Implementing and operator care program> a focus on the continuous Improvement and sustainability elements > building a program by the people and for the people – ensuring engagement > strengthening the process and communication skills of the organization to uncover the already existing Technical capability mike Gehloff, strategic account director, Gpallied / usa

12.20 | lunch with networking Zone

we.coNect process tracK (2)systematical plant asset & asset risk management – systematical & integrated asset life cycle management13.30 | case studyimplementation of an sustainable asset life-cycle-management (lcm) concept by linking production and finance data of sap erp to improve the plant availability – a case study of a multi-purpose production> Implementation of an sustainable asset life cycle Management (lcM)> Transparency of maintenance regarding activities and costs> Monitoring and reporting tool based on sap R/3> optimization of Maintenance processes dr. ernst Keck, head of asset strategy and business processes - doZ,roche diagnostics GmbH / Germany

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14.10 | case studyValue oriented maintenance – the strategic dimension of the spanner and its impact on reliability centered maintenance> economic significance of maintenance – facts and figures> The conMoto study: status quo of Maintenance and asset Innovation in the process industry> The conMoto MaintenancescoreTest© – more than 120 analyzed production plants / sites over the last 7 years> key elements for Reliability centered Maintenance> proven results by implementing Maintenance excellence> case studies in the process industrynils blechschmidt, senior partner and head of the competence center Maintenance excellence & asset Innovation, conmoto consulting Group GmbH / Germany

14.50 | case studyasset care excellence (ace ) – improving asset performance and asset lifecycle management withworld-class tpmrobert christman, global Reliability coordinator, Genzyme / a sanofi company / usascott morris, associate director of programs, Genzyme / a sanofi company / usa


we.coNect challeNGe your peersIn these round tables, each with one moderator, the participants interact, describe & discusstheir specific issues, approaches and solutions regarding the conference topic.

16.00 | parallel Round Tables

Round Table 1rcm – reliability centred maintenancereinhold maeck, director center of competence and projects, boehringer ingelheim pharma GmbH / Germany

Round Table 2plant asset management> cMMs Tools > Mes & cMMsdr. ernst Keck, head of asset strategy and business processes - doZ, roche diagnostics GmbH / Germany

Round Table 3maintenance planning & scheduling> What is the right level for fda readyness? > experience with implementation of TpM?Giuseppe mirra, director Reliabilty & Maintenance operations, sanofi pasteur / usa

Round Table 4risk based maintenance & maintenance integration> how to achieve high performance preventive maintenance? > Role of health authorities on maintenance management, risk based maintenance experience, operator asset caremichael teasdale, senior director operation excellence, baxter bioscience / usa

we.coNect process tracK (3)improving Quality & compliance and increasing operational excellence with manufacturing execution systems 17.00 | case studyexcellence in technology transfers: a key success factor for pharmaceutical productionreinhold maeck, director center of competence and projects, boehringer ingelheim pharma GmbH / Germany

17.40 | case studycost improvement program in maintenance organizations – understanding the key business strategies for effective maintenance program on a global level > design of a methodology to review / optimize cost structures> designing an integrated platform between engineering, operations and technology to dramatically improve reliability > assessing ways of maximising success for your workforce to drive your maintenance initiatives towards excellence> deployment across all Merck serono sites> benefits & feedback lessons learnedJean-pol Gossuin, vice president, head of engineering & Technology Techops, merck serono / switzerland

18.20 | case studyValue-optimized maintenance at bayer cropscience (which is about the complementary integration of oee and reliability centered maintenance to deliver optimum business performance)> delivering continuous improvement in plant reliability and integrity through a collaborative cross-functional approach involving management, engineering, operations and maintenance> creating a reliability focus that involves everyone from management to shop floor personnel> Making common sense common practice – bridging the gap from the theoretical to the practical> Meeting agreed stakeholders’ expectations through a sound, well executed and well measured reliability programnick crosby, global Reliability and Integrity Manager,bayer cropscience lp / usa

aGeNdacoNfereNce day 1 | Monday, 5Th noveMbeR 2012

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8.30 | Welcome and introduction by we.conecT and the chair chair: conor troy, owner, conor troy & partner consultancy / switzerland

8.40 | case studymaintenance involvement in the different phases of a new production lines project to achieve a successful production start up and lasting reliability> case study of a capital investment in the plant to increase production capacity> analysis of maintenance team profile requirements to join in the project> project phases review and real participation in each case of different profiles of the maintenance team> commissioning of new production lines and learningFrancisco ruiz, head of process engineering and Manufacturing Maintenance, boehringer ingelheim s.a. / spain

9.20 | case studythe technical shiftbook as pharmaceutical logbook at bayer Healthcare for reliability centered maintenance> Management of work safety> failure analysis> single communication platform > gMp documentation> organizational change Management for Reliability centered maintenancethomas Gosmann, global process Teamlead, center of excellence, bayer Healthcare aG, organization & information / Germany

we.coNect cost coNtrol strateGies tracK 10.00 | case studymaintenance diagnostics (overhaul about diagnostics), maintenance documentation and cmms – specification, recommendation for implementation, usage experiencetomislav turk, Maintenance Manager assistant, belupo pharmaceutical and cosmetics / croatia


we.coNect world caféthe World café will be initiated with short statements11.00 | short statementseach World café moderator gives a short description of the specific café

short statement RoI cafépaperless maintenance processes – illusion or state of the art reality?requirements for implementation of true electronic maintenance processes > process design and technical requirements for cMMs> Inclusion of outsourced services in paperless documentation> Resource allocation and planning routines> Training and skill development > value proposition for the pharmaceutical businessdr. christian Jurisch, head of Technical services pharma, Johnson & Johnson / switzerland

short statement audit & Inspection caféGmp-requirements in qualification and maintenance of facilities and criticality and findings during inspections / preparing of audits> Maintenance engineers are the unsung heros of the pharmaceutical manufacturing process!? (a.d.M.brown) > legal requirements (eu-gMp, Who-gMp, cfR etc.) > statistics and experiences from inspection of health authorities > how to pass an inspection (aspects for preparation)Hans-peter Vogels, ph.d., director Quality assurance / Qualifiedperson, meda manufacturing GmbH / Germany

aGeNdacoNfereNce day 2 | Tuesday, 6Th noveMbeR 2012


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20.00 | networking dinner

ResTauRanT | habel weiNKulturluisenstraße 19 | 10117 berlin | www.wein-habel.de





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short statement Training & development caféchallenges in site transformation & implications for maintenance & engineering – How to get a maximum of stability & reliability in manufacturing processes in a fast changing environment? cormac ahern, site operational excellence lead, pfizer / ireland

short statement oee caféHow to increase oee in a pharmaceutical site?> Implementing oee and its analysis from the beginning> understanding the root-causes of equipment stoppages> Rebuilding the maintenance planning> correct data analysis and decision making> Training operation and Maintenance teams> using the right equipment to the right product – by using some tools from TpMFrank Hirsch, Manager support center & finishing operations, abbott GmbH & co KG / Germany

11.10 | start world café part 1 | each sessioN lasts 30-40 miNuteswe.conecT and the chair open the World café, explaining the principles and set the World café etiquette.

12.30 | lunch with networking Zone

13.30 | start world café part 2 | each sessioN lasts 30-40 miNutes

14.40 | World café panel discussionpresentation of the key results of the World café


we.coNect coNtractor aNd supplier maNaGemeNt tracK 15.20 | case studymaintenance-Friendly design: integrating engineering maintenance into project design> designing for maintenance access> The hidden Maintenance Technician> designing hvac systems for a potent Manufacturing facility> Installation & Removal> Illustrative real life case studiesdr. mike battrum, head of engineering, aesica pharmaceuticals / uK

we.coNect techNical coNtrolliNG & Kpi’s tracK 16.00 | case studyHow to improve maintenance in the pharmaceutical industry using right First time approach > Maintenance program “how do we start“, this will help categorize the equipment before it gets integrated with the maintenance strategy of the company> defining critical equipment> equipment Ranking> fMea> how to develop a pM> Why pM’s fail> planning and scheduling> proactive vs. Reactive Maintenance Giuseppe mirra, director Reliabilty & Maintenance operations, sanofi pasteur / usa

16.40 | case studychange from mono to multipurpose production – a risk management approach> current situation (mono product facility) & upcoming business needs on site> challenges associated with the introduction of new apIs> examples of project management tools: risk management, stakeholder analysis> project insights: lessons learned, temporary solution, plan how to get to the final layout fulfilling all business needsoliver Kärst, head of Technical services, Warner chilcott deutschland GmbH / Germany

17.20 | closing words from the chair and end of the conference

roi café training & development café

audit & inspection café oee café

roi café training & development café

audit & inspection café oee café


for more detailed iNformatioNabouT ouR speakeRs and InTeRacTIve segMenTs please vIsIThttp://pharma-maiNteNaNce.we-coNect.com

We aRe lookIng foRWaRd To WelcoMIng you!

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