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CPTCente r for Pharmaceutical Training

Attend CPT's Powerful Two-Day Conference . . .

FDA's Quality Systems Aand Six Sigma forPharmaceuticalsM ain Co nfe ren c e M arc h 30-31 , 2004P r e -C o n f e r e n c e Wo r k s h o p s M a r c h 2 9 , 2 00 4Cro w ne P laza Hote l Ph i lad e lph ia , PA

No other event on the market can arm you with as many end-userperspect ives on how to:

Benefit from Six Sigma in a pharmaceutical manufacturing environment Develop an audit program to meet FDA's systems-based approach Implement an effective internal audit program Review the evolution of QSIT from medical devices to pharmaceuticals Build a culture of compliance Gain practical knowledge on how to utilize risk management tools: FMEA and HAACP Integrate lean principles in the manufacturing of sterile pharmaceuticals Assess Part 11 compliance Develop and implement a systems-based inspection plan Improve quality and reduce costs in a highly competitive marketplace

FEATURED SPEAKERS INCLUDE: Pre-ConferenceWorkshopsMonday, March 29,2004

A. MASTER CLASSDeveloping andImplementing aSystems-BasedInspection Plan

B. How to ManageProcess Deviationsand FailureInvestigations Utilizina Systems BasedApproach

C. Change Management:A Step-by-Step Guideon How to Help ChangeEfforts Succeed

Joseph Fortuna toSenior Director, Global Standardsand Compu ter ComplianceCOVANCE

Nigel P. Holcom beDirector, QA Compliance andCertificationASTRAZENECA

Scott L. Grossma nDirecto r, Regulator y Affairs

MITSUBISHI PHARMAAMERICA INC.

Penelope PrzekopAssociate Director, QualityManagementJOHNSON & JOHNSON

John B. WilmothProduction Project Manager,Medical Techn ologyALCON LABORATORIES

Larry PriceMBA, CQ Manager,CQ A, CQA-HACCPAssociate Director,DC Quality ProgramsDistribution Op erationsWYETH PHARMECUTICALS

John O'NeillManager Q C/Stability Op erationsSANOFI-SYNTHELABO

RESEARCHKenneth J. O'ConnorSenior Validation EngineerBAUSCH & LOMB

Jennifer Marie Zuzik-SowerQuality/PerformanceImprovement SpecialistSix Sigma Black BeltROCKINGHAM MEMORIALHOSPITAL

PRESENTED BY:

A DIVISION OF:

SPECIAL THANKS TO:

RECOMMENDED PROFESSIONALORGANIZATION:

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CONFERENCE AT A GLANCE

DAY O NE - TUESDAY MARCH 3 0, 20 047:45 Continen tal Breakfast and Registration8:15 Chairperson's Welcome and O pening Remarks8:30 Current State of the Industry: Pharmaceutical cGMPs for the 21st Century:

A Risk-Based Approach9:15 Developing An Audit Program to Meet FDA's Systems-Based Approach10:15 Morning Refreshment Break 10:45 Impleme nting Process Excellenc e Techniques and Strategies in the

Pharmaceutical Industry11:30 How to Utilize ISO 9000:2000 to Establish Continuous Improvement to

Your Processes12:15 Lunch1:45 Managing the Globalization of the Q uality Systems Approach in Your

Organization2:30 Assessing Part 11 Co mpliance- An Auditor's Perspective

3:15 Afternoon Refreshment Break 3:45 The Evolution of QSIT from Medical Device to Pharmaceuticals4:30 Building a Culture o f Compliance5:15 Conclusion of Day O ne Gene ral Session

DAY TWO - WEDNESDAY - MARCH 31, 200 48:00 Continen tal Brea kfast8:30 Chairperson's Day Two Opening Remarks8:45 Impleme nting a Q uality Systems Approac h Within Your O rganization9:30 Utilizing Risk Management Tools: Failure Mode Effect Analysis (FMEA)

and HAACP10:15 Morning Refreshment Break 10:45 Creating an O rganizational Framework using Q uality Mana gement Concep ts:

Black Belt not Required11:30 Integration of Lean Principles in the Manufacture of Sterile Pharmaceuticals12:15 Lunch1:45 Continuous Improvement Initiatives: Improving Q uality and Reduc ing Costs in a

Highly Competitive Marketplace2:15 The Fundamentals of Six Sigma3:00 Afternoon Refreshment Break 3:30 Application of Six Sigma Methodology to Pharmaceutical Processes4:15 How Six Sigma Benefits a Pharmaceutical Manufacturing Environment5:00 Conclusion of Conference

PRE-CON FERENCE WO RKSHIPS - MONDAY, MARCH 29, 2004

Who Will Attend:At FDA's Quality Systems Approach and Six Sigma

for Pharmaceuticals, you will have the uniqueopportunit y to interact and network wi thprofessionals in the Pharmaceutical andBiotechnology industries:

Quality Assurance

Quality ControlQuality ManagementQuality EngineeringOperational/Process ExcellenceRegulatory AffairsComplianceAuditing

HERES JUST A SAMPLE OF

COMPANIES THAT HAVE ATTENDEDOUR PAST PROGRAMS:

If You Attend Only One Conference This Year, Make SureIt's FDA's Quality Systems Approach . . . Heres why:At FDAs Quali ty System Approach, Here are Just a Few of the Questions that Wil l be Answered. .

3MAbbott Labo ratoriesAlkermesAllerganAltanaAlza CorporationAmgenAmylin Pharmaceuticals, Inc.AstraZenecaAventisAVID Bio ServicesBanzigerBanksBaxter HealthcareBayer Corp.Beckman Coulter, Inc.Berlex Labora toriesBiogenBiopureBoehringer IngelheimBristol-Myers SquibbCell TherapeuticsCentocorCepha lon, Inc.Charles River LaboratoriesChesapeake BiologicalLaboratoriesCleveland ClinicFoundationColumbia UniversityCopernicusDey LabsDurameo Pharmaceuticals

EisaiEli Lilly and CompanyEthiconForest LaboratoriesFaulding Puerto Rico, Inc.FujisawaGenentechGenetics InstituteGenzymeGilead Science sGlaxosmithklineHoffmann -La RocheIDEC PharmaceuticalsICN PharmaceuticalsImmunex

Indiana UniversityJanssen PharmaceuticalsJohnson & JohnsonJoint Programs Office of BioDefenseLa Jolla PharmaceuticalsLigand PharmaceuticalsMerck National Cancer InstituteNational Institute of HealthNeutrogenaNovartisNovo No rdisk OrganonOrtho-McNeilOtsukaPaddoc k Labo ratoriesParexelPerkin Elmer Instrume ntsPfizerPharmaciaProcter and GamblePurdue Frederick Purdue PharmaQuintilesRaytheonRoche DiagnosticsSankyoSanofi-SynthelaboSchering AG

Schering PloughSchwarz PharmaSeronoSolvaySugenTakedaTeva PharmaceuticalsThera CardiaViropharmaVista Bialogic CorporationVivometricsWest Pharmace uticalsWyeth AyerstYamano uchiPharmaceuticals

A. 8:00AM-1:00PMMASTER CLASS Developingand Implement ing aSystems-BasedInspection Plan

B. 1:30pm-4:30pmHow to Manage ProcessDeviations and FailureInvestigations Utilizing aSystems Based Approach

C. 5:00PM-8:00pmChange Management: AStep-by-Step Guide on Hto Help Change EffortsSucceed

What is Six Sigma?

How can Six Sigma be applied to thepharmaceutical industry?

How can ISO 9000:2000 be used toimprove productivity?

What are the key areas of FDA'ssystems based inspections?

What are the challenges in building aninternal audit program?

What is necessary to manage auditsusing qua lity systems?

How can risk be communicated in anorganization?

How does Six Sigma relate to qualitysystems?

Wha t is QSIT?

How do es Q SIT differ from FDA'sSystems-Based Inspections?

What a re the organizational issueswithimplementing a quality system?

How can Six Sigma and Lean beapplied in the laboratory?

What is Failure Mode and EffectsAnalysis (FMEA)?

How can FMEA be applied to thepharmaceutical industry?

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A Note From CPT About WorkshopsCPT workshops are short, interactive training courses attached to our conferences to give our participants real world, practical experience through exercises, discussions and

case study analyses. CPT workshops are specially designed to optimize sharing of best practices and practice tips through an in-depth look at niche topics. These vital sessionsare designed to give you an "A to Z" roadmap approach to tackling common challenges.

M A S TER C LA S S 8:00 A M - 1:00 PMADeveloping and Implementing a Systems-Based Inspection Plan

FDA has implemented a Systems-Based approach to GMPinspections. Activities found in drug firms are organized into sixsystems that are sets of operations and related activities. Controlof all systems helps to ensure the firm will produce drugs that aresafe, have the identity and strength, and meet the quality andpurity characteristics as intended.

This program establishes a systems approach to provide for a uniform level of CGMP assessment, which is used in determining the overall acceptability of the firm.

The measure of success come s from being prepared. Pharmaceutical companiesneed to take a p roactive approach in evaluating their systems and assessing whetherthey are in a "state of control". Attend ing this workshop will help to e nsure tha t yourfirm will meet FDA's expectations. Key topics include:

Learning how FDA conducts systems-based inspections An in-depth review of the six systems Tips on preparing for a systems-based inspection Assessing whether you are in compliance Discussion of system related inspection findings

About Your Workshop Lead er:Phyllis Lambridis is President of Framework Quality Systems, LLC, a consulting

firm that specializes in building the foundation for FDA compliance. She has 20 yearsof industry experience in quality control, quality assurance, regulatory affairs andcompliance. Her expertise lies in providing guidance on preparing for andresponding to FDA inspections, assisting with investigation report and SOP writing andbuilding quality systems to ensure GMP compliance.

Ms. Lambridis was Vice President, Corporate Compliance for Halsey DrugCompany, Inc., where she was responsible for all Quality Assurance, Quality Control,Regulatory Affairs and Validation act ivities. Prior to joining Halsey Ms. Lambridis wasDirector of Corporate Policies, Standards & Systems at Watson Pharmaceu ticals. Ms.Lambridis was employed at Barr Laboratories, Inc. from 1987 to 1998 where she heldvarious positions of increasing responsibility in both Regulatory and Quality. She wasactively involved in the court proceedings in United States vs. Barr Laboratories, Inc.and was later appointed as FDA Liaison and Director of Regulatory Compliance.

Ms. Lambridis received her bachelor's degree in Microbiology from RutgersUniversity and her Master's degree in Bacteriology from Wagner College.

How to Manage Process Deviations and FailureInvestigations Utilizing a Systems Based ApproachProcess deviations and their impact o n daily operations can be monumental.

Handling these deviations in a compliant manne r is paramount to succe ssful release of product. This workshop is designed to give the attendee an overview of the processesassociated with process de viations, their impact on change control, approaching thedeviation via a systemic approach and conducting an investigation. The workshopwill include the following key topics:

Assigning and delegating roles and responsibilities Detailing your investigative process Identifying corrective action strategies

Summarizing the investigational process in the proper documentation format FDA defined systems Process deviation "system"

Change control "systems" What requires an investigation? SOPs for different departments Notification of a potential investigation

Review and verification of the situation requiring an investigation Evaluation of the immediate area or process for problems

Expansion of the investigation Who does the investigation?

Writing the investigation - what the investigation should contain CAPA Time frames Approval Impact and further notification

About Your Workshop Lead er:As the Vice President of Compliance Insight, Inc., Troy Fugate will work with

companies regionally and worldwide in the pharmaceutical and biotechnologyindustries in the fields of Compliance and Quality Assurance. His consulting realmincludes parenteral, tablet, capsule, oral liquid and API regulation compliance. Troy'sprimary strengths are Quality Assurance activities with emphasis in quality systems,risk assessment and systemic audits.

5-HOURINTERACTIVE

LEARNINGWORKSHOP

3 To Register C a ll 800-882-8684 E ma il info@iqpc.com Or V isit w ww.cptpharma.or g

PRE-CONFERENCE WORKSHOPS - MONDAY, MARCH 29, 2004

AFTERN OO N WORKS HOP 1:30 PM - 4:30 PMB

EVENING WORKS HOP 5:00 PM - 8:00 PMC

Fortune 1000 companies are facing a multitude of forces driving the need forchange, quality and improvement. Its a familiar list: global competition, acceleratingproduct lifecycles, new technology, regulatory pressures, margin squeeze and so on. Yetagainst this backdrop, virtually all quality professionals report feeling that their insightsand experience are not being fully used, that they know more than is being utilized, thatthey can make even greater contributions. This appears to be so even in the mostsuccessful initiatives, and even as people report feeling stressed and overworked. Whenasked why, most attributions about cause point to inadequacies in the user system,securing critical resources, getting the user community committed, navigating conflictingpriorities, unrealistic demands, or problems in the relationships between groups. Puttingthese themes together, it appears that quality is not instant pudding. Theres more to itthan adding methodology or resources. Sometimes, even the well-intentioned efforts of senior management cant shout and hope change into place.

This workshop explores the domain and principles of helping change efforts succeed.Part of our time will look at best practices - the things you can adopt and adapt from outthere in industry - what works - in terms of change management. Part of the workshopwill invite you to consider the aspects of change management that happen from theinside out - and learning to coach others constructively. This interactive workshop takes aholistic and balanced view - and provides you with principles, tools and practice in be ingmore effective at helping change succeed. Key topics include:

Changing practices and processes Changing mindsets and attitudes Changing relationships

About Your Workshop Lead ers:Cynthia L. Palka, M.S., RAC, CEC, is President of Future Map, Inc., a professional

coaching and consulting firm that assist individuals and companies in thepharmaceutical and biotech industries with their change management efforts. Ms.

Palka has be en working in the life sciences arena since 1992. She was e mployed atWyeth Research as a Medicinal Chemist, and has held positions as an executiverecruiter in the life sciences practices of large and boutique search firms. Ms. Palkaformed her own company in 2000. Ms. Palka is a Certified Empowerment Coach(CEC) by the Institute of Professional Empowerment Coaching (IPEC) and a memberof the International Coach Federation (ICF). She holds a BS in Chemistry and MS inBiochemistry and is a Regulatory Affairs Certified (RAC) professional.

Bill Dunnington is Managing Director and Founder of PerformanceDevelopme nt Strategies, LLC, a management consultancy based in Virginia. He is aseasoned general management executive with broad experience in the Fortune 500,who helps executives:

Understand the business situation, especially customer nee ds, expectations andpriorities.

Assess internal processes, competencies, culture and capabilities in this context. Design and lead change strategies that bring these together to accelerate

tangible gains.With over twenty years experience, the solutions he brings reflect an a ppropriate

mix of tools or disciplines - customer value management, strategy formulation,organization de sign, competency and culture development, marketing andcommunications, technology integration, leadership development, action learning,process quality and change management, measurement analytics and programmanagement. Mr. Dunnington is a versatile facilitator and process consultant byexperience and a practical strategist by instinct. He has had a rich variety of roles andexperiences while leading quality improvement inside two Fortune 100 firms, andconsulting with practitioners who are leading Baldrige, Six Sigma or ISO initiatives. Heholds a BA in Organization Psychology and a Masters in IT Strategy andManagement.

Change Management: A Step-by-Step Guide on How toHelp Change Efforts Succeed

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DAY ONE:TUES D AY, M ARC H 30, 20047:45 Continental Breakfast and Regist rat ion

8:15 Chairperson's Welcome andOpening Remarks

Nigel P. Holcombe

Director, QA Compliance and CertificationASTRAZENECA

8:30 Current State of the Industry: Pharmaceut icalcGMPs for the 21st Century: A Risk-BasedApproach

On August 21, 2002, the Agency launched a two-year initiative,Pharmace utical cGMPs for the 21st Ce ntury: A Risk-Based Approach. Thisobjective of this initiative is to encourage the early adoption of newtechnological advances by the pharmaceutical industry, facilitate industryapplication of modern quality management techniques, includingimplementation of quality systems approaches, encourage implementationof risk-based approaches that focus both industry and Agency attention oncritical areas, ensure that regulatory review and inspection policies arebased on state-of-the-art pharmaceutical science, and enhance theconsistency and coordination of FDA's drug quality regulatory programs.This session will discuss the following key topics:

Why FDA launched this initiative FDA's e xpectation s Update on the progress of this initiative How industry and FDA need to work together using science-based

policies and procedures to facilitate innovation within the existingregulatory framework

The steps FDA has taken to streamline and improve its internalprocesses

Phyllis LambridisPresidentFRAMEWO RK QUALITY SYSTEMS, LLC.

9:15 Developing An Audit Program to Meet FDA'sSystems-Based Approach

Internal audits are a proactive approach to ensuringFDA com pliance . This case study add resses thecorporate d emands of building an aud it program,effective strategies and the changes in approachrequired for complying to FDA's new systems-basedapp roach. Key topics include:

Understanding the key areas of FDA's system-based inspections Defining resp onsibilities for you r aud it program Administrative and staffing issues Differences b etween the Europe an ap proach to auditing and FDA

Nigel P. HolcombeDirector, QA Compliance and CertificationASTRAZENECA

10:15 Morning Refreshment Break

10:45 Implementing Process Excellence Techniquesand Strategies in the Pharmaceutical Industry

This session will highlight the expe riences from qua lity improveme ntprojects within the pharmaceutical industry. Delegates will learn how toidentify best practices that can immediately be applied throughout theirorganization. The session will also give a quick overview of theories such as,'Quality Systems are not processes' to application tolls such as, 'meeting freeWednesdays'. Real life results from quality system improvement programswill also be presen ted. The se ssion will also cover such topics as:

Program Approaches - What can we do to revise systems in operatingplants? Is Six Sigma a new or old approach?

Quality Systems - What are they, and how do they differfrom processes?

Success Factors - How much 'top management support' do you need ?

Is this a strategic project? Communication - Does reporting status overwhelm our ability to

gathe r relevant data? How much project contro l is eno ugh?Tim OswaldProject ManagerQUANTIC GROUP

11:30 How to Utilize ISO 9000:2000 to EstablishContinuous Improvement to Your Processes

The process approach is used by both the ISO 9000:2000 standard andFDA's quality system ap proac h regulation. Key elemen ts of both arecon tinual improvemen t. Establishing a thorou gh unde rstanding of how toimplement them is critical to succe ss. This session will discuss the followingkey topics:

What the ISO 9000:2000 standard is The relationship between the ISO 9000:2000 standard and FDA's

quality systems approach How to use the ISO 9000:2000 standard and FDA's quality system

approach regulation to improve your processes Why the ISO 9000:200 0 standard is important to the p harmaceutical

industry How to make continual improvements cost-effective

Linda BankoskiPresidentQ UALITY LEADERSHIP ASSOCIATES

12:15 Luncheon for Speakers and Attendees

1:45 Managing the Globalization of the QualitySystems Approach in Your Organization

Pharmaceutical and biotech companies have affiliates or parentcom pan ies in international countries. As a result, these co mpa nies need tobuild internal audit programs with a global perspe ctive in mind. If yourcompany operates internationally, your quality systems will be held to aglobal standard and harmonization will take on a specific corporateapp lication. This session will address the many facets involved withglobalization of your systems. Included are:

International standards; where they are similar and how they differ Designing quality unit structure to fit a multi-national corporation Defining the standards and requirements for Japan, EU and the US Building information systems to aid the harmonization effort Utilizing International SOPs to guarantee uniformity Implementing a uniform procedure and standard based on product

type and location Conducting audits to ensure b est practices Overcoming the language barrier through design, skill and spirit

John O'Ne illManager QC/Stability OperationsSANO FI-SYNTHELABO RESEARCH

2:30 Assessing Part 11 Compliance:An Auditor's Perspective

This real-world implementation case study will highlight the following: Assessing part 11 compliance Overview of the new guidelines Auditing internal systems How the FDA guidelines are affecting auditing Identifying gaps in complying with regulation and FDA guidelines

Joseph Fortuna to

Senior Director, Global Standards and Computer ComplianceCOVANCE

3:15 Afternoon Refreshment Break

3:45 The Evolution of QSIT from MedicalDevice to Pharmaceuticals

As the FDA continues to perform system-based inspections atpharmaceutical companies much can be learned about the inspectionprogram for me dical devices. Called Q SIT, the 1 999 med ical deviceinspection technique was a radical change in FDA inspection approaches.This presentation will discuss the QSIT program, its history, benefits andrelationship with traditiona l FDA inspe ctions. Pharmac eutical systems andprocesses will also be discussed. As the primary leader of FDA's QSIT

CASESTUDY

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program Tim Wells will discuss: QSIT and quality systems with a unique FDA perspective How does QSIT currently affect medical device vs. Pharmaceutical Implementing appropriate techniques and strategies to align yourself

with Q SIT principlesTim Wells*PresidentQ UALITY HUB*Tim is a 24-year veteran of FDA and co-authored "FDA Guide to the

Inspection of Quality Systems (QSIT) Handbook".

4:30 Building a Culture of ComplianceEffective strategies used by FDA and industry for the management of risk include:

Focus on high risk/high economic impact situations Focus on risk independent of level of actual risk Focus on high profile cases to create a psychological deterrent Collaborative risk managementThis presentation will describe the above four risk management strategies

and cite spec ific examples of the ir use. A fifth industry strategy for risk mana geme nt is to build a culture of com pliance . Althou gh the US InspectorGeneral, the US Sentencing Commission, and corporate management havediscussed "culture of compliance", the concept remains vague. "Culture of com pliance " is a type o f organizationa l culture. Definitions and attributes of a culture of compliance will be presented along with a description of positive outcomes associated with establishing a culture of compliance.Step s to build a culture of compliance will be d escribed. This presen tation

will show that consideration of aspects of organizational culture is beneficialfor the establishment of an effective corporate compliance program, andthat building a "culture of compliance" can be considered as an additionalstrategy for organizational risk management.Scott L. GrossmanDirector, Regulatory AffairsMITSUBISHI PHARMA AMERICA INC.

5:15 Conclusion of Day One General Session

DAY TWO:WEDNESD AY, M ARC H 31, 2004

8:00 Continental Breakfast8:30 Chairperson's Welcome and

Opening RemarksNigel P. HolcombeDirector, QA Compliance and CertificationASTRAZENECA

8:45 Implementing a Quality Systems ApproachWithin Your Organization

This session identifies "Critical Success Factors" necessary for a companyto realize implementation of a suitable and effective quality system.Emphasis is placed upon developing a strategy that is based uponreasonable business systems and processes that are suitable and effective,while me eting applicable governing requ ireme nts. Learn key elements toperforming an organizational assessment that takes into consideration

different situational factors that can have an affect on a company'scom pliance status. Attend ee s will also bene fit from an in dep th discussionconcerning what it take to comprehend a "Corporate Culture" and tomana ge the change proc ess. Key topics include :

How to prepare for the implementation process - what are the criticalsteps you must take?

How to obtain buy-in and increase communication with yourmanagement?

Is the ROI mea surable? How ca n you assess if it is working? How to effectively gain company intelligence from conducting

management interviews? How to compare and co ntrast a systems-based approach with

traditional approaches? What situational factors and contingencies ne ed to be considered?

What are the five major activities required to manage thechange process?

J. Glenn GeorgeFounder and PresidentQ RC ASSOCIATES, LLC

9:30 Util izing Risk Management Tools: Failure ModEffect Analysis (FMEA) and HAACP

FMEA and HAACP represent two major risk management tools mostfrequ ently utilized by the me dical device industry. These to ols are now

applied to the pharmaceutical industry. Companies that manufacturedevices and drugs have a fundamental understanding of risk analysis tollslike FEMA and HAACP. However, the que stion is: what doe s the FDAmean when they talk about risk management and ho w do es that differ fromrisk analysis? This session will cover the following:

Risk management vs. risk analysis Applying risk based tools for validation planning and ongoing Determination of operational compliance

Larry PriceMBA, CQ Mgr, CQ A, CQA-HACCPAssociate Director, DC Q uality ProgramsDistribution OperationsWYETH PHARMECUTICALS

10:15 Morning Refreshment Break

10:45 Creating an Organizational Framework usingQuality Management Concepts: Black Belt notRequired

Have you he ard the strong message that in order to create the culturalchange n eede d for full implementation of a Q uality Manageme nt Approach,high-level suppo rt is essent ial? Are you intereste d in implemen ting SixSigma, ISO 9000:2000, and/or Malcolm Baldrige concepts but don't have ablack belt, don't know how to get one, can't get one, or have otherpriorities? Goo d news! There are ways in which Middle Manage men t canincorpo rate key Q uality Manageme nt conce pts today. By unde rstandingand using these concepts, you can begin to change the culture of yourorganization from the inside out. You d on't have to wait until your CEOdeclares that SIX SIGMA is the answer, bringing in consultants or starting aBlack Belt training program. This type o f high-level support wo uld be

fantastic, but do n't wait. By impleme nting the key con cep ts listed b elowand others, you can begin making a difference in your organization today:

Process Focus/Do cumentation Customer Focus Data Driven Management Limitless Boundary Collaboration

Penelope PrzekopAssociate Director, Quality ManagementJOH NSON & JO HNSON

11:30 Integration of Lean Principles in t heManufacture of Sterile Pharmaceuticals

For several years, JIT and Lean mana geme nt tech niques have b ee n usedeffectively in the m anufacturing of medical devices. The results have bee nmeasured in cost savings and more importantly, in the improvement of

product quality by creating an environment that fosters compliance.Recently, pharmaceutical companies have become interested in programssuch as six sigma to: improve quality, promote teamwork throughout theorganization, improve service levels and red uce co sts. At the same time,the use of Lean principles is under consideration to streamline all facets of the o pe ration. This session will discuss the elemen ts of Lean ma nagem entby defining techniques such as 5S, Value Stream Mapping and Kanbans.Two projects will be reviewed to d emo nstrate how tech niques for productsterilization an d mac hine set-up were improved throu gh the u se of Leanprinciples.Kennet h J. O'ConnorSenior Validation EngineerBAUSCH & LOMB

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12:15 Luncheon for Speakers and Attendees

1:45 Continuous Improvement Init iatives:Improving Quality and Reducing Costsin a Highly Competi tive Marketplace

This presentation addresses how to set up a Continuous ImprovementInitiative in your organization and greatly reduce manufacturing costs whilemaintaining excellent p roduc t quality. This conce pt is key in today's highlycom pe titive marketplace . Learn how to get senior managem ent buy-in andparticipation from employees at all levels of the organization as well as theimportan ce of a rewards and reco gnition pro gram. Key topics include:

Strategies for implemen tation Ways to stimulate employee involvement Keys for your purchasing group to reduce manufacturing costs

John B. WilmothProduction Project Ma nager, Medical TechnologyALCO NE LABO RATO RIES

2:30 The Fundamentals of Six SigmaThis presentation is designed to define and explain the fundamentals of

Six Sigma me tho do logy. The se ssion will also look at the d eta ils of: "Sigma","Six Sigma", and the "Six Sigma m eth od ology". The sp ea ker will pre sent theSix Sigma methodology steps, tools used within each step, and how thesteps move us to process improvement. There will also be a section that willencou rage you to question your own p rocesses, suppliers, and customersalong the "Six Sigma Mindset" and put you in the "data thinking" mode. Keytopics include:

Realistic expe ctations for Six Sigma dep loyment Vision/key strategies Measurement Developing and applying a Six Sigma strategy Project identification and selection Training and certification

Jennifer Marie Zuzik-SowerQuality/Performance Improvement SpecialistSix Sigma Black BeltROCKINGH AM MEMORIAL HO SPITAL

3:15 Af ternoon Refreshment Break

3:45 Application of Six Sigma Methodologyto Pharmaceut ical Processes:This case study addresses the successes Wyeth Pharmaceutical has had

in applying Six Sigma tools to resolve and improve processes within theirorganization. The experienc e of develop ing astrategy to implement and deploy Six Sigma; how itcan be linked to the organization goals & objectivesand the impo rtance of mana geme nt involved. Thepresentation will share the most commo n o bstaclesencountered and how to orchestrate a winningschem e. Establishing the logistic of selecting the right peo ple and th e rightprojects. The importa nce o f assemb ling the right project team s to ensureproject succe ss. Key topics include :

Reduce variation and obtain bottom line benefits by addressingparticular elements focusing on value added activities

Effort initiatives to institutionalize Six Sigma systematic approach:How to m ake it part of operations

Partnering with our customers in fulfilling their wants and needs,achieving sustainable re sults

Examples on how Six Sigma techniques can be applied to sterilemanufacturing

How Wyeth addresses situations and opportunities and effectivelymeasure results utilizing key process metrics

Turning data into the most valuable elemen t when ide ntifying areas of improvement

Iris CorderoDirector, Business Process Management and Process ExcellenceWYETH AYERST LEDERLE

Mark A. DeutschManager, Global Training & CIWYETH PHARMACEUTICALS

4:30 How Six Sigma Benefits a PharmaceuticalManufactur ing Environment

As complex economic, social and business issues continue to placepressure on the Pharmaceutical industry, it is evident that a quantum changeis required across the supply chain across many areas -- including qualityand compliance; capability to manufacture and work agilely across anetwork of partners. This presentation will provide manufacturing, supplychain and quality professionals with a view of where the industry is headingover the next three to five years. Delving into the key areas Pharmaceuticalmanufacturing leaders should be concentrating their efforts on, this talk will,

in particular, focus on two drivers that are causing pressure on the industry:therapeutic product evolution a nd a new regulatory compliance agenda.Key topics include:

There will be a new focus on the individual that will require new,highly spe cific pa tient d ata and highly spe cific man ufacturing facilities

Companies will partner with MCO's and/or physicians for patient data Integration will be imperative between customer facing technology

and the supp ly chain Factories will be product specific - traditional, mass customized and

targeted products Process compliance will be measured and driven to new levels of

performance Can six sigma principles effectively reduce cycle time for the pilot

plant and drug manufacturing process? How doe s the reduced c ycletime translate into dollars for company savings

How to implement Design of Experiments into your robustness tests How would you implement Six Sigma into a sterile manufacturing

environment?Jim Pren dergastLead Partner, Pharmaceutical Supply Chain Management,IBM GLOBAL SERVICES

5:15 Conclusion of Conference

CPT Conferences Available on CD Rom!Can't attend the conference? While there's no substitute for being

onsite, you can now benefit from all of the presentations, exhibitorinformation and other key strategies and insights passed along at the

event by purchasing a specially prepared FDA's Quality SystemsApproach and Six Sigma for Pharmaceutical CD Rom.The CD Rom is a permanent reminder of the conference and

contains all of the detailed PowerPoint presentations that were preparedby the speaker faculty and presented at the event; a full colorconference brochure; detailed informationabout the event sponsors and exhibitors alongwith information about how your company canget involved in future events; and upcomingIQPC events! The cost of the CD Rom is only$499 - a mere fraction of the registration price!To reserve your CD Rom call IQPC'sCustomer Service Department at800-882-8684.

CASESTUDY

About the Event Organizer . . .The Center for Pharmaceutical Training (CPT)is the world's leading provider of training forpharmaceutical professionals. Focusing ontraining for a variety of pharmaceuticalfunctions, including drug discovery, good

laboratory practice (GLP),good manufacturingpractice (GMP), good clinical practice (GCP), quality control (QC),quality assurance (QA), validation, 21 CFR Part 11 and other regulatoryissues, and more. At the Center for Pharmaceutical Training, we knowhow essential GXP compliance is to keeping your projects on time andon budget. That's why we're here to provide you with the tools you needto meet your goals. Whether you're in drug development, electronic datacapture, microbiological monitoring, packaging, metrology, or computersystems and data management, the Center for Pharmaceutical Trainingcan help. Visit www.cptpharma.org.

CPTCenter for Pharmaceutical Trainin

6 To Regis ter C a ll 800-882-8 684 Ema il info@iqpc.com Or V isi t w ww.c ptpharma.org

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SPONSORSHIP and EXHIBITION OPPORTUNITIESFor more detailed information on these opportunities please contact,

Mat thew Singer at 212-885-2769 or email him at matthew.singer@iqpc.com.

C a l l : 800-882-8684 o r 973-812-5165 F a x : 973-256-0205 24-Ho ur s -A-D a y M a i l : C PT/ IQPC

1 5 0 C lo v e R o a dLi t t l e Fa l l s , NJ 07424-2157

@E-M a il : in fo @c pt ph ar m a .o r g We b : w w w .c p t ph a rm a .o r gIMPORTANT! To speed registration, provide the product code located on the back covereven if it is not addressed to you! MAKE CHECKS PAYABLE TO: CPT/IQPC* CT residents or peopleemployed in the state of CT must add 6% sales tax.For personalized help in choosing the right program for youand your staff, simply call George Zlatin at 212-973-3312 ore-mail gzlatin@cptpharma.org now.

Payment PolicyPayment is due in full at the time of registration and includes lunches, refreshmentsand detailed conference materials. Your registration will not be confirmed untilpayment is received and may be subject to cancellation.

CPT's Delegate Substitution, Cancellation andPostponement Policies

You may substitute delegates at any time. For cancellations received in writing, youwill receive a 100% credit to be used for up to one year from the date of issuance.There will be no refunds for cancellations. In the event that CPT cancels an event,delegate payments at the date of the cancellation will be credited to a future CPTevent. This credit will be available for up to one year from date of issuance. In theevent that CPT postpones an event, delegate payments at the date of postponementwill be credited towards the rescheduled date. If the delegate is unable to attend onthe rescheduled date, the delegate will receive a 100% credit representing paymentsmade towards a future CPT event. This credit will be available for up to one year fromthe date of issuance.

No refunds will be available for cancellations of postponements. CPT is notresponsible for any loss or damage as a result of a substitution, alteration orcancellation/postponement of an event.

CPT shall assume no liability whatsoever in the event this conference is cancelled,rescheduled or postponed due to a fortuitous event, Act of God, unforeseenoccurrence or any other event that renders performance of this conferenceimpracticable or impossible. For purposes of this clause, a fortuitous event shallinclude, but not be limited to: war, fire, labor, strike, extreme weather or otheremergency.

Please note that speakers and topics were confirmed at the time of publishing,however, circumstances beyond the control of the organizers may necessitatesubstitutions, alterations or cancellations of the speakers and/or topics. As such, CPT

reserves the right to alter or modify the advertised speakers and/or topics ifnecessary. Any substitutions or alterations will be updated on our web page as soonas possible.

Lodging Information: Sessions for the conference & workshops will be held at:

CROWNE PLAZA PHILADELPHIA CENTER CITY1800 Market Street Philadelphia, Pennsylvania 19103

Phone: 215-561-7500 Fax: 215-561-4484

MAKING TRAVEL PLANS? For discounted flight reservations on most majorcarriers, make sure you or your Corporate Travel Departmentcontacts CPT Events Official Travel Planner, Candy Eardleyof Travel Forum toll-free at 1.877.852.4135 or locally at973.942.0100. Candy can also be reached via email atcandy@travelforuminc.com.

2004 CPT/IQPC All Rights Reserved.The format, design, content and arrangement of thisbrochure constitute a trademark of IQPC. Unauthorized reproduction will be actionable under theLanham Act and common law principles.

ELECTRONIC FUNDS TRANSFER:Greater Community Bank, 150 Clove Road, Little Falls, NJ 07424 Phone 973-890-5444 Account Name: International Conference InstituteABA/Routing #: 021206566 Account#: 21104620Federal Tax ID#: 13 3839754Reference: Please include the name of the attendee and code 2049.02

REGISTER BY PHONE FAX MAIL E-MAIL OR WEB SITE

SPECIAL THANKS TO:

Inspection Monitor is the onlynewsletter with the strategic information

you need about FDA inspections, including what FDA inspectors are reallylooking for, how companies are responding to 483 and EIR citations, whichcompanies are targeted for enforcement proceedings and who's makingFOIA requests for FDA 483s and EIRs.

Validation Times is the monthlynewsletter with weekly e-mail alerts thatputs you in the shoes of FDA field

inspectors and tells you how your competition fared in an audit.

Warning Letter Bulletin is the onlyservice that summarizes all warning and

untitled letters, categorized by YOUR INDUSTRY. Every two weeks you canread summaries of all warning and untitled letters, learn what FDA found onits inspections, and read company responses!

Pharmaceutical Technology. Essential to themanufacturing process for over 27 years, PharmTech expertly covers all aspects ofpharmaceutical/biopharmaceutical manufacturing.

From applied research to equipment to drug delivery to informationtechnologies to contract services to biotech trends Pharm Tech meets theneeds of 33,741 BPA Qualified subscribers with authoritative, technicallyaccurate editorial. www.pharmtech.com

PharmaVOICE is the executive forum that allows businessleaders to engage in a candid dialogue on the myriadchallenges and trends impacting the life-sciences industry.

PharmaVOICE reaches more than 17,000 U.S.-based executives who influencebusiness strategies and affect change. Published monthly, PharmaVOICEprovides readers with insightful and thought-provoking commentary in a multiple-perspective format through its forums, topics, and articles that cover a range ofissues from molecule through market. To Raise Your VOICE, contactfeedback@pharmavoice.com. Website:www.pharmavoice.com

American Pharmaceutical Review is the leading review of business andtechnology for the pharmaceutical industry throughout NorthAmerica. Each issue offers American PharmaceuticalReview's 30,000 readers unbiased editorial on the followingtopics: PAT, drug delivery, information technology, research &

development, analytical development and control, equipment and facilitymanufacturing, regulatory affairs and outsourcing. For your FREE subscription,please fill out our on-line form at www.americanpharmaceuticalreview.com

Recommended Professional OrganizationDon't miss the opportunity to join the only organization, TheInternational Society of Six Sigma Professionals (ISSSP),committed to promoting the adoption, advancement andintegration of Six Sigma in business.The ISSSP Communitysupports this mission through advocacy and awareness efforts;professional recognition and development; and by serving as aninformation and referral source. Become a Professional Member

of ISSSP for $150.00 (a 25% discount) by registering online at www.isssp.comand using the Discount Code: IQPCEVENTS

*Please Note: An individual may only utilize one form of discount per registration. Please determine the maximum discount you may qualify for prior to registration.

7 To Regis ter C a ll 800-882-8684 E ma il info@iqpc.com Or V is it w ww.cptpha rma.org

P a c k a g eO p t i o n s :

PLATINUM PACKAGE:Conference, All Workshops plusMaster Class

Brochure DiscountsExpires

February 13, 2004After

February 13, 2004

Save $200$3,498* $3,698*

Master Class, Please Add: Save $100$699* $799*

Workshops, Please Add:Choose B C Save $100$400 each* $500 each*

Conference Only: Save $100$1,799 $1,899

8/14/2019 IQPC-FDA_3-30-31-04

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FDA's Quality Systems Apand Six Sigma forPharmaceuticals

Attend CPT's Powerful Two-Day Conference . . .

M ain Co nfe ren c e M arc h 30-31 , 2004P r e -C o n f e r e n c e Wo r k s h o p s M a r c h 2 9 , 2 0 04Cro w ne P laza Hote l Ph i lad e lph ia , PANo other event on the market can arm you with as many end-user per-spectives on how to:

Benefit from Six Sigma in a pharmaceutical manufacturing environment Develop an audit program to meet FDA's systems-based approach Implement an effective internal audit program Review the evolution of QSIT from medical devices to pharmaceuticals Build a culture of compliance Gain practical knowledge on how to utilize risk management tools: FMEA and HAACP Integrate lean principles in the manufacturing of sterile pharmaceuticals Assess Part 11 compliance Develop and implement a systems-based inspection plan Improve quality and reduce costs in a highly competitive marketplace

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Card #____________________________________Exp. Date___/___ CD ORDERS. Send me ___sets of CD at $499 per set Please keep me informed via e-mail about this and other related events

*Please add 6% sales tax if your workplace is in Connecticut (CT).

CPT/IQPC150 Clove RoadLittle Falls, NJ 07424-2157

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When registering by phone, please provide the product code above.

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T o

R e g i s t e r : phone: 800-882-8684

or : 973-812-5165fax: 973-256-0205email: INFO@IQPC.COMonline: WWW.CPTPHARMA.ORG

Event # 2049.02/SM/KF

CPTCenter for Pharmaceutical Training

PRESENTED BY:

A DIVISION OF:

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Conference plus 2 Workshops & Master Class Conference plus 1 Workshop & Master Class Conference plus Master Class Conference plus 2 Workshops Conference plus 1 Workshop Conference Only

See page 7 for pricing details