MediaPartners;

Rowland A. Yovonie, PhD; PECertified Six Sigma Black BeltGroup Leader, Quality Engineering & Statistical GroupHOFFMANN-LA ROCHE, INC.

Dr. Ronald D. Snee Principal, Process and Organizational Excellence TUNNELL CONSULTING

David M. Stephon Vice President, Quality Assurance ADOLOR CORPORATION

Our Distinguished Faculty Includes:John GallardoSenior Quality EngineerHOFFMAN-LA ROCHE, INC.

Jinus MoghbeliSenior ManagerCorporate QualityAMGEN

John WilmothProduction Project ManagerALCON LABORATORIES

Stan MastrangeloDirector, Information and Policy, Medical Devices,Corporate and Regulatory StandardsABBOTT LABORATORIES

David DillsDirector of FDA Regulatory Compliance and Validation ServicesFOCUS CVS

Joseph P. CeresaSenior Auditor, Quality OperationsWYETH PHARMACEUTICALS

TO REGISTER CALL 1-800-882-8684 OR VISIT US AT WWW.IQPC.COM

November 14-16, 2005 • Sheraton Society Hill Hotel • Philadelphia, PA

• Johnson & Johnson utilizes Six Sigma methodology without formal training• Alcon Laboratories practices Continuous Improvement initiatives• Hoffmann-La Roche integrates Risk-Based methodology in pharmaceutical

process validation strategy• Johnson & Johnson utilizes strategic planning for quality• Adolor Corporation manages change control effectively• Hoffmann-La Roche benefits from application of Failure Mode and Effects

Analysis in pharmaceutical packaging• Abbott Laboratories understands and utilizes risk analysis toolsAnd many more...

Hear Industry Case Studies and Gain Practical Knowledge on How:

FDA Quality Systems and

SIX SIGMA for Pharmaceuticals and Biotechnology

Present the 5th Annual

Early Bird Discounts Available!See page 7 for more information

First 10 registrants receive acomplimentary copy of Six Sigma forBusiness Excellence, written byconference speaker Penelope Przekop,Director of Global Quality Managementat JOHNSON & JOHNSON (J&J)

2 FDA QUALITY SYSTEMS AND SIX SIGMA FOR PHARMACEUTICALS AND BIOTECHNOLOGY

Pre-Conference Workshops MONDAY, NOVEMBER 14, 2005

Many organizations have embraced the continuousimprovement programs such as TQM and Six Sigmathrough the development of a formalized ProcessExcellence program. Lean manufacturing is Qualityphilosophy that can greatly strengthen theeffectiveness of an organizations process excellenceinitiative. Lean manufacturing concentrates onminimizing the consumption of resources that addsno value to the finished product. This is achieved byoptimizing those processes that bring value to yourproduct thereby eliminating wasted time, money, andproductivity. Topics covered in this workshop include:• Differences between Six Sigma and Lean Manufacturing

• Lean deployment challenges for process drivenindustries

• How to identify and define the Value Stream• Tools for optimizing the Value Stream and how to

apply them• How to deploy "Kaizen teams" and how to achieve

breakthrough improvements• Metrics for describing a lean organization

About Your Workshop Leader:Bikash Chatterjee is the Chief Operating Officer of

Pharmatech Associates Inc., a full service consulting firmservicing the pharmaceutical, medical device/diagnostic

and consumer industries providing guidance, trainingand deployment services . Prior to his current position,Mr. Chatterjee was Vice President, PharmaceuticalOperations for Aradigm Corporation where wasresponsible for establishing their process development,engineering, validation, facilities and manufacturingcapabilities. He also served as Plant Manager forBoehringer-Mannheim's disposable coagulation testingdivision. Mr. Chatterjee is a Six Sigma Master BlackBelt and has extensive experience in the design andimplementation of quality systems and hasimplemented Six Sigma and Lean manufacturingsolutions in the pharmaceutical industry.

A 8:00am – 11:00am Applying Lean Manufacturing to Your Organization’s Process Excellence Program in the Pharmaceutical and Biotech Industry

Have you heard the strong message that in order tocreate the cultural change needed for fullimplementation of a Quality Management Approach,high-level support is essential? Are you interested inimplementing Six Sigma, ISO 9000:2000 and/orMalcolm Balridge concepts but don't have a black belt?Don't know how to get one? Can't get one? Or have otherpriorities? Here's the answer: There are ways thatmiddle management can incorporate key QualityManagement concepts in its processes. No longer doyou have to wait until corporate decides that Six Sigmais the answer, brings in consultants or starts a Black Belttraining program. This workshop focuses on how you canbegin making a difference in your organization today.

Key concepts include: • Process Focus • Customer Focus & Collaboration • Data Driven Management • Strategic Planning for Quality

This workshop provides attendees with thestrategic context for implementing a Six Sigma-related program that reflects the goals of thecompany as well as the specific imperatives of theirpersonal organization, whether it consists of twopeople or over a hundred people.

About Your Workshop Leader: Penelope Przekop, MSQA, is currently the Director of

Global Quality Management for the Johnson & Johnson(J&J) Benefit Risk Management (BRM) organization. In her

role, Ms. Przekop is responsible for BRM controlleddocuments, quality and compliance metrics, andCorrective Action Plan (CAP) management. Inaddition, she serves as the key BRM liaison with J&JQuality Assurance and authored the J&J Primer forDrug Safety Compliance. Prior to joining J&J, Ms.Przekop held positions of increasing QualityManagement-related responsibilities at HoechstCelanese, Novartis, Wyeth, and Covance, a ContractResearch Organization, as well as consultingassignments with Pfizer and Rhone-Poulenc. Ms.Przekop is an American Society for Quality (ASQ)Certified Quality Manager. Her book, Six Sigma forBusiness Excellence: A Manager's Guide to SupervisingSix Sigma Projects and Teams, McGraw-Hill, becameavailable in bookstores everywhere in September 2005.

B 11:15am – 2:15pm Black Belt Not Required: Six Sigma for the Functional Manager Luncheon will be served during this workshop.

The pharmaceutical industry, like many otherindustries, is experiencing a growing need to improveits performance. Regulatory compliance issues,quality problems, side effects of drugs, the need toreduce costs; the list of problems is getting longer.How to go about this improvement in a systematicand focused manner is the question. Fortunately aworld-class body of improvement technology existsknown as Six Sigma. There are other effectiveimprovement methods used in the pharmaceuticalindustry such as Lean manufacturing and ProcessAnalytical Technology that reduce the risk of non-compliance to Good Manufacturing Practices. Thisoften results in a lot of non-productive discussionabout which improvement approach to use in a givensituation. The prudent person uses all theseapproaches, selecting the right tools for the problemat hand. To implement such a philosophy one needs

a holistic approach that integrates the useful toolsfrom all approaches into a common methodology. Aholistic approach to improvement is the subject ofthis workshop. Emphasis is on:• Deciding what tools to use on what kind of

problems. • A problem solving and process improvement

methodology • Making effective use of improvement methods

when an organization is not engaged in a top-downorganization-wide improvement initiative

• Sustaining the gains of improvement projects• Using improvement to drive organizational culture

change • Pharmaceutical applications which include diverse

areas such as yield improvement, deviation reduction,batch record release, quality systems improvement,clinical development and technology transfer.

About Your Workshop Facilitator:Dr. Ronald D. Snee is Principal, Process and

Organizational Excellence at Tunnell Consulting. Hehas an outstanding record of leadership in processand organizational improvement in a wide range ofindustries, including pharmaceuticals, food,chemicals, telecommunications, insurance, financialservices, newspapers and clinical diagnostics. Dr.Snee is an American Society for Quality Shewhartand Grant Medallist and a Fellow of ASQ and theAmerican Statistical Association. He has publishedmore than 155 articles and coauthored 2 books onSix Sigma with Roger W. Hoerl of General Electricentitled Leading Six Sigma – A Step-by-Step GuideBased on Experience at GE and Other Six SigmaCompanies and Six Sigma Beyond the Factory Floor -Deployment Strategies for Financial Services,Healthcare and the Rest of the Real Economy

C 2:30pm – 5:30pm Utilizing a Holistic Approach to Performance Improvement

This workshop presents CAPA-compliant techniquesfor gathering, organizing, and analyzing manufacturing,lab, and quality data into timely, logical,comprehensive investigations suitable for internal useand FDA review. Learn to conduct robust root causeanalyses on unexpected discrepancies, to understandand eliminate recurring problems by selectingappropriate corrective and preventive actions, and todocument investigation data analysis effectively. Wewill discuss applications of the method to commoncause "Six Sigma" style improvement efforts. This workshop utilizes a case study and encourages

audience participation. Topics covered include: • Understanding special cause differential diagnosis

problem analysis • Applying special cause techniques to common

cause process improvements • Selecting appropriate corrective and preventive

actions for process improvement • Implementing documentation techniques to

prevent FDA 483s, inspection findings, andwarning letters

About Your Workshop Facilitator: Wade Speir, Senior Consultant, Kepner-Tregoe's

Pharmaceutical Practice, specializes in Quality &

Compliance and Manufacturing issues. Mr. Speir hasspent the last ten years applying Kepner-Tregoe'sProblem Solving, Decision Making, Risk Analysis andProject Management processes to specific issues inmanufacturing and cGMP CAPA processes for manyleading pharmaceutical firms. He has worked in thepharmaceutical practices of Booz-Allen & Hamilton, PAConsulting and The Life Sciences Group. Mr. Speir is afrequent speaker at industry events and has publishedarticles on pharmaceutical quality and projectmanagement issues.

D 5:45pm – 8:30pm Special Cause Differential Diagnosis Problem Analysis Dinner will be included during this workshop

3 TO REGISTER, CALL 1-800-882-8684 OR VISIT US ONLINE AT WWW.IQPC.COM/PHARMAIQ

7:30 Continental Breakfast and Registration

8:30 Welcome Address and Opening Remarks from the Conference Director and Conference ChairpersonSapna MehtaConference Director, PharmaIQIQPC

Rowland A. Yovonie, PhD; PECertified Six Sigma Black Belt, Group Leader, Quality Engineering &Statistical Group, HOFFMANN-LA ROCHE, INC.and Conference Chairperson

8:45 Continuous Improvement Initiatives: Secure the Future!In this session, our speaker guides the audience through the steps for

implementing a continuous improvement initiative in your organization. He providesan overview of a Continuous Improvement program structure and discusses how toobtain senior management buy-in and support. Other topics include:• Methods to get employee participation at all levels of the organization• How to recognize and reward employees for their participation• Overview of Lean Manufacturing and Six Sigma• Methods to "brainstorm" ideas for continuous improvement projectsJohn WilmothProduction Project ManagerALCON LABORATORIES

9:30 Integrating Risk-Based Methodology in Pharmaceutical Process Validation Strategy

The Pharmaceutical Industry has not yet fully integrated a risk-based methodology intoProcess Validation Strategy. The 1987 industry guideline on Process Validation requiresthat all processes need to be validated. Process understanding and associated risk are notexplicitly stated in the guideline. For Process Validation to be customer focused, reliable,and cost effective, risk management must be an integral part of the overall ProcessValidation Strategy. This is particularly important in the emerging process technologies inPharmaceutical Manufacturing, where product failure can be caused by the failure of themanufacturing process.

This presentation will discuss the conceptual differences amongst the 1987Pharmaceutical Process Validation guideline, 1999 Global Harmonization Task Force,FDA 1997 Quality System Requirements for Medical Devices, and FDA 2004 cGMPGuidelines (Guidance?) for the 21st Century. The presentation covers:• Comparison of Pharmaceutical and Medical Device Industry Process Validation Guidelines• Verification, Qualification, and Validation• The rationale for applying a risk assessment• What is a Risk-Based Methodology?• Why use a Risk-Based Methodology?• How to implement a Risk-Based MethodologyRowland A. Yovonie, PhD; PECertified Six Sigma Black Belt, Group Leader, Quality Engineering & Statistical GroupHOFFMANN-LA ROCHE, INC.

10:15 Morning Refreshment and Networking Break

10:45 Managing Change Control Effectively • Methods to maintain a state of control despite ever-changing demands • Change control concepts and regulatory requirements • Ideas for improving your existing change control SOPs and forms • Recognition of items that MUST be on your change control forms • Create, review, approve, distribute and store change documents • Coordinate changes that cross multi-departmental boundaries • Meet FDA and other regulatory authorities change control requirements with proof

of compliant, well-managed changes • Respond to emergency or temporary changes • Documenting change justifications • Follow up and closure to implemented changes David M. Stephon Vice President, Quality Assurance ADOLOR CORPORATION

11:30 Surviving an FDA Audit: Thinking Like an FDA Officer-CASE STUDIES

As the backbone for every company or facility, your CAPA program is an integralpart of your organization’s functionality and CAPA programs are known as the immunesystem to determine how healthy or unhealthy the business unit. Moreover, the FDA iswatching. But how can you prove to the FDA that you are in control and incompliance? This session addresses issues with CAPA programs and defines criticalconsiderations you must know when planning and preparing for an FDA audit. Someof the activities associated with developing, deploying and implementing a CAPAsystem includes collect information, analyze information, identify an investigateproduct and quality problems, and take appropriate and effective corrective and//orpreventive action to prevent their recurrence. Utilizing real-life issues and casestudies, this session sparks interactive discussions with an industry leader who isready to share his perspectives with you. Topics addressed include:• What the FDA looks for in your CAPA program, documentation red flags and trigger points • Examining common FDA reasons for the 483 and warning letter and addressing best practices • Conducting a risk-based assessment for your facility• Preparing for an FDA audit and inspection - preparing and managing the

audit/inspection process • Remediation tactics and strategiesDavid DillsDirector of FDA Regulatory Compliance and Validation ServicesFOCUS CVS

12:45 Luncheon for Speakers and Attendees

1:45 Risk Management in a Regulated IndustryThis session will focus on the fundamental premise of risk management as it

applies to the regulated industry. With the new initiatives on process and productivityimprovement ideas such as six-sigma, managers in a regulated industry are oftenrequired to shift their paradigms. This session discusses how six-sigma processes andlean thinking can effectively integrate the principles of risk management and ensurequality and compliance.Shamik PanditPresidentGMP SCIENTIFIC, INC.

3:00 Application of Failure Mode and Effects Analysis in Pharmaceutical Packaging

In this session, the speaker will provide an overview of the purpose and benefitsof an FMEA and further discuss a successful case study using this risk analysis toolfor evaluation of a packaging process in response to customer complaints. KeyTopics include:• What is an FMEA • Types of FMEA • Benefits of FMEA• When to use FMEA• FMEA Process• Elements of an Effective FMEA Process• Packaging Process FMEA - Case StudyJohn GallardoSenior Quality EngineerHOFFMANN-LA ROCHE, INC.

3:45 Applying Lean Principles to Your Six Sigma InitiativesSeparately, Lean and Six Sigma have changed the face of the pharmaceutical

business. Together, they become an important tool for improving product and processquality, production efficiency, and across-the-board profitability. Lean Six Sigmaintroduces today's most dynamic program for streamlining the performance of boththe production department and back office, providing with the cost reduction andquality improvements to stay one step ahead of competitors. Pharmaceuticalcompanies are now starting to realize the impact of how both lean principles and sixsigma processes could have on the success of their business. This panel discussionwill include core concepts on Lean and Six Sigma.

Panel Facilitator and Chairperson:Rowland A. Yovonie, PhD; PE, Certified Six Sigma Black BeltHOFFMANN-LA ROCHE, INC.

Panel Members:Bikash Chatterjee, Chief Operating Officer, PHARMATECH ASSOCIATES, INC.John Wilmoth, Production Project Manager, ALCON LABORATORIES

4:30 Day One Concludes

Mid-Conference Workshop TUESDAY, NOVEMBER 15, 2005

DAYONE Tuesday, November 15, 2005

With the current pharmaceutical industry financialpressures, it has become increasingly important todevelop solid programs that positively impact the bottomline. In order to develop an effective operationalexcellence program, particularly one with a Six Sigmafocus, several key aspects of the program must carefullybe developed. Key aspects that will be discussed in thisworkshop include: defining areas of opportunity,measuring and collecting validated data, analyzing thedata with respect to the particular processes, movingforward with improving your processes, and controllingthat improved performance. In this workshop we will

also review an example study that can be used to justifymanaging batch records in an electronic, paperlessenvironment. Examples of several tools will be includedin the workshop.

About your Workshop FacilitatorsMichalle Adkins is a Sr. Principal Engineer in the Life

Sciences Industry Center at Emerson Process Managementin Royersford, PA. Michalle has 13 years ofpharmaceutical industry experience in engineering,automation support, computer validation, production,and planning. In addition to project work, she is also

currently active with the Emerson Operational Excellenceconsulting program.

Christopher P. Amstutz is the Director of Software QualityAssurance at Decision Management International inBradenton, FL. Christopher has 6 years ofpharmaceutical industry experience in compliance,implementation, and computer system validation. Inaddition to Quality Assurance work, he has participatedin Emerson Operational Excellence consulting program.

E 4:45pm – 7:45pm Maximizing Your Operational Excellence Program Dinner will be included during Workshop

4 FDA QUALITY SYSTEMS AND SIX SIGMA FOR PHARMACEUTICALS AND BIOTECHNOLOGY

7:30 Continental Breakfast

8:30 Recap of Day One from the Conference ChairpersonRowland A. Yovonie, PhD; PECertified Six Sigma Black BeltGroup Leader, Quality Engineering & Statistical GroupHOFFMANN-LA ROCHE, INC.

8:45 Strategic Planning for Quality: Applying Six Sigma in the Trenches [Keynote Speaker]

Despite what you may have heard, middle management can implement theunderlying concepts of Six Sigma in the day-to-day. To do this, managers must firstunderstand the concepts, believe in them, and create a strategy that weaves them intothe culture of their personal organizations. In this session, managers of all levels willlearn how to improve the quality of their organizational outputs by:• Creating a management framework (and standing behind it)• Organizing their organizations for quality (no matter what the size)• Following the DMAIC cycle for their organizations (only as appropriate)• Continuously monitoring and improving their organizations (maintain the momentum)Penelope Przekop, MSQAHead, Global Quality Management JOHNSON & JOHNSON (J&J)

9:45 Quality Systems at Amgen, from Development to DeploymentDrug, pharmaceutical and biologics manufacturing firms are increasingly being audited

under a quality systems approach. In addition, Sept 29, 2004 FDA Guidance for Industry,Quality Systems Approach to Pharmaceutical current Good manufacturing regulations,emphasizes the importance of the Quality Systems, Risk based approach and Quality byDesign. This presentation describes Amgen’s proactive approach to Quality ManagementSystem and striving to be “Best in class” with the following elements:• Being proactive, recognizing the need and obtaining senior management support• Conducting a business evaluation• Developing a strategy and Quality Plan• Communication and pilot• Execution and deployment• Measurement, Continuous improvement and MaintenanceJinus MoghbeliSenior ManagerCorporate QualityAMGEN

10:30 Morning Refreshment Break

11:00 Understanding Risk for the Pharmaceutical IndustrySince FDA went public with their initiative for Pharmaceutical cGMPs for the 21st

Century, "risk" has become one of the most used, and misunderstood, terms in theindustry. Companies that manufacture devices and drugs have a fundamentalunderstanding of risk analysis tools like FMEA and HACCP, but what does FDA meanwhen they talk about "risk management" and how does that differ from "risk analysis"?Key topics include:• A brief history of risk science• General principles and tools of risk analysis• Preparing for FDA’s risk management initiatives-inspections, submissions, quality

systems• Summary of recent FDA activities-guidances, regulatory activity, presentationsStan MastrangeloDirector, Information and Policy, Medical Devices, Corporate and Regulatory StandardsABBOTT LABORATORIES

ProcessDevelopment.net is the mainweb information portal dedicated to

chemical process R&D. Updated on a regular basis, theunique mix of exclusive interviews, specialist supplierlistings, events, news and new products makes this a one-stop-shop for essential information. For reference thereare links to research centres, journals, books, reviews andmarket reports.

Published by Espicom Business Intelligence,World Pharmaceutical Markets provides a

complete and detailed review of over 60 keypharmaceutical markets around the globe. Each reportprovides an insightful interpretation of market trends anda range of information from economic/demographic datathrough to health status, services, personnel and fundingto regulation and domestic production. In addition to thisall country reports now include unique and original 5-yearmarket forecasts - all in one convenient, monthly updatedservice. To start your subscription online or to downloadfurther information, go to www.espicom.com/wpm

MarketResearch.com is the leadingprovider of global business

intelligence on markets, industries, and companies. Wehelp professionals stay ahead of market developments andtrends with expert data and analysis. See how we canhelp you make better decisions today. VisitMarketResearch.com or call 1-800-298-5699 to speakwith a research specialist. FDA Quality:http://www.marketresearch.com/redirect.asp?progid=5313

Published by Espicom Business Intelligence,Pharmaceutical Companies Analysis (PCA)provides a complete and detailed review of

over 40 of the world’s major pharmaceutical companies.Each report provides a full review of the company’sactivities, from its origins to its latest corporate activity,including mergers and acquisitions, agreements,divestitures, major purchasing contracts and litigation.Sections are included on products, international activitiesand R&D, as well as a full, in-depth five year financialanalysis. To start your subscription online or to downloadfurther information visit www.espicom.com/pca

American Pharmaceutical Review is the leadingquarterly review of business and technology for thepharmaceutical industry throughout North

America. Each issue offers American Pharmaceutical Review's30,000 readers unbiased editorial on the following topics:materials, information technology, research & development,analytical development and control, equipment and facilitymanufacturing, regulatory affairs and outsourcing.www.americanpharmaceuticalreview.com

American Pharmaceutical Outsourcing is a bimonthlyjournal dedicated to pharmaceutical andbiopharmaceutical contract services. Each issue

reaches over 12,000 key decision makers involved in clinicalresearch, regulatory affairs and the outsourcing of contractservices in the pharmaceutical and biopharmaceutical industriesin North America. For your FREE subscription, please fill out ouron-line form at www.americanpharmaceuticaloutsourcing.com

11:45 Conducting Effective Audits of Your Internal SystemsHow does FDA’s quality system approach impact the way to conduct an internal

audit of your facility? By understanding FDA Guidance Documents: “DrugManufacturing Inspections, Program 7356.002”; and “cGMPs for the 21stCentury: A Risk Based Approach”, this session explores what is necessary tomanage your audits using the quality systems. Key topics include:• Audit program goals • Developing strategies for inspecting the process• Relationship management during an audit• Communication by Auditors Joseph P. CeresaSenior Auditor, Quality OperationsWYETH PHARMACEUTICALS

12:15 Luncheon for Speakers and Attendees

1:30 Quality AgreementsIn this era of lean manufacturing, rapid pharmaceutical product development andglobal clinical trials, companies are utilizing contract manufacturing organizations(CMO) to facilitate the process. Once the decision has been made to use theservices of a CMO, the sponsor who holds the Investigational or MarketingApplication (e.g., IND, CTA, CTX, NDA, BLA, MAA, ANDA) for the drug product,biological product or medical device is responsible for ensuring current GoodManufacturing Practice (cGMP) compliance. One means of documentingcompliance requirements for both the sponsor and the contracted organization isthe Quality Agreement. This session will discuss the following aspects of theQuality Agreement to ensure manufacturing compliance:• Rationale for the Quality Agreement• Responsibilities for writing, reviewing and approving• Regulatory requirements• Quality Agreement format and content• Managing changes to the Quality Agreement• Role of the Quality function to ensure adherence to the Quality AgreementFelicia Ford-Rice, M. Mgmt, RACDirector of Quality AssuranceACAMBIS, INC.

2:45 Developing a Simplified Change Control System for Your Quality System and Utilizing Six Sigma Principles

It is well-known throughout the pharmaceutical and biotechnology industries thatChange Control is necessary for ensuring compliance with FDA regulations. It is up topharmaceutical companies to develop effective systems that successfully manage andtrack change. One of the greatest challenges that people who practice change controlare struggling with today is dealing with the complicated nature of how many systemsare built. Often, this complexity results in people avoiding the system altogether,ultimately defeating the purpose of the system in place. This session instructsattendees on what is needed to build a formal Change Control system and how thissystem can be simplified with fewer requirements. Key points discussed include:• Definition of a Change Control system• System criteria and requirements• Six Sigma principles as it applies to Quality System• Creating and using Change Control forms related to compliance and documentation• Effectively applying a simplified system• Post-implementationSuggy ChraiPresident and CEOCHRAI ASSOCIATES, INC.

4:00 Closing Remarks and Conference Concludes

DAYTWO Wednesday November 16, 2005

Media Partners

Continued on next page ➔

TO REGISTER, CALL 1-800-882-8684 OR VISIT US ONLINE AT WWW.IQPC.COM/PHARMAIQ5

REGISTER BY PHONE, FAX, E-MAIL OR WEB SITEWeb: www.IQPC.com/pharmaIQPhone: 1-800-882-8684 or 973-256-0211Fax: 973-256-0205 24 Hours A DayMail: International Quality & Productivity Center

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FDA and government employees are eligible for other savings, please contact Customer Serviceat 1-800-882-8684 for further details. Valid ID must be presented on-site at the conference.

Note: One form of discount is available per registrant.

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 event number: 2049.05

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

IQPC Cancellation, Postponement and Substitution Policy: You may substitute delegates at anytime. IQPC does not provide refunds for cancellations. For cancellations received in writingmore than seven (7) days prior to the conference you will receive a 100% credit to be usedat another IQPC conference for up to one year from the date of issuance. For cancellationsreceived seven (7) days or less prior to an event (including day 7), no credit will be issued.In the event that IQPC cancels an event, delegate payments at the date of cancellation willbe credited to a future IQPC event. This credit will be available for up to one year from thedate of issuance. In the event that IQPC postpones an event, delegate payments at thepostponement date will be credited towards the rescheduled date. If the delegate is unableto attend the rescheduled event, the delegate will receive a 100% credit representingpayments made towards a future IQPC event. This credit will be available for up to one yearfrom the date of issuance. No refunds will be available for cancellations or postponements.IQPC is not responsible for any loss or damage as a result of a substitution, alteration orcancellation/postponement of an event. IQPC shall assume no liability whatsoever in theevent this conference is cancelled, rescheduled or postponed due to a fortuitous event, Actof God, unforeseen occurrence or any other event that renders performance of thisconference impracticable or impossible. For purposes of this clause, a fortuitous event shallinclude, but not be limited to: war, fire, labor strike, extreme weather or other emergency.Please note that speakers and topics were confirmed at the time of publishing, however,circumstances beyond the control of the organizers may necessitate substitutions, alterationsor cancellations of the speakers and/or topics. As such, IQPC reserves the right to alter ormodify the advertised speakers and/or topics if necessary. Any substitutions or alterations willbe updated on our web page as soon as possible.

Please note that speakers and topics were confirmed at the time of publishing, however,circumstances beyond the control of the organizers may necessitate substitutions, alterationsor cancellations of the speakers and/or topics. As such, IQPC reserves the right to alter ormodify the advertised speakers and/or topics if necessary. Any substitutions or alterations willbe updated on our web pages as soon as possible.

If you have a dietary restriction, please contact our Customer Service Department at 1-800-882-8684 to discuss your specific needs.

2005 IQPC. All Rights Reserved. The format, design, content and arrangement of thisbrochure constitute a trademark of IQPC. Unauthorized reproduction will be actionable underthe Lanham Act and common law principles.

Sessions for the Conference and Workshops willbe held at:

Sheraton Society Hill Hotel 1 Dock Street, Philadelphia, PA 19106Phone: 215-238-6000 • Fax: 215-238-6652

To secure reduced rates, please contact the hotelat least four weeks prior to the conference andbe sure to mention the conference name.Note: Contact hotel for direction and transportation suggestions.

LODGING INFORMATIONSPONSORSHIP and EXHIBIT OPPORTUNITIESSponsorships and Exhibits are excellent opportunities for your company to showcaseits products and services to high-level, targeted decision makers attending the FDAQuality Systems and SIX SIGMA for Pharmaceuticals and Biotechnology. PharmaIQ andits FDA Quality Systems and SIX SIGMA for Pharmaceuticals and Biotechnologyconference helps companies like yours achieve sales, marketing and brandingobjectives by setting aside a limited number of event sponsorships and exhibitspaces - all of which are custom-tailored to help your company create a platform tomaximize its exposure at the event.

For more information on Sponsoring or Exhibiting at FDA Quality Systems and SIX SIGMA for Pharmaceuticalsand Biotechnology, please contact Shannon Forrester at 1-212-885-2719 or via email at sponsorship@iqpc.com.

Vendor Pricing: Add $300 Service Fee

"Very informative…[this presentation] sparked good discussion." – Principal Scientist, Hoffman-LaRoche, Inc."Excellent…One of the most informative and useful presentations in the conference!" – Associate Director, Corporate Quality Systems, Genzyme Corporation

"Excellent detail and depth…Thanks for sharing!" – Director, Quality Engineering, Johnson & Johnson"Great presentation with very useful information." – Executive Director, Quality Operations, Watson Pharmaceuticals

"A very good conference…The speakers brought a lot of experience and background." – Director, Quality Operations, Wyeth Pharmaceuticals

Here’s what Past Attendees had to Say

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Platinum Package Save $500 Save $400 Save $200Conference Plus 4 Workshops $3,615 $3,715 $3,915

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Gold Package Save $300 Save $200 $3,057 Conference Plus 2 Workshops $2,757 $2,857

Silver Package Save $200 Save $100 $2,528 Conference Plus 1 Workshop $2,328 $2,428

Conference Only Save $100$1,899 $1,999 $1,999

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and analysis of GMP validation issues,including software, computer andprocess validation, with a subscriptionto Validation Times. Examine FDAinspection reports for key validationcitations. Validation Times also comeswith a weekly email news alert FDAcompliance and enforcement news.Visit www.FDAINFO.com for moreinformation or contact us at (800) 776-5105 or (703) 779-8777,E-mail: service@fdainfo.com.

Warning Letter Bulletin isthe only service thatsummarizes all warning and

untitled letters, categorized by YOUR INDUSTRY. Everytwo weeks you can read summaries of all warning anduntitled letters, learn what FDA found on its inspections,and read company responses!

Inspection Monitor is theonly newsletter with the

strategic information you need about FDA inspections,including what FDA inspectors are really looking for, howcompanies are responding to 483 and EIR citations, whichcompanies are targeted for enforcement proceedings andwho's making FOIA requests for FDA 483s and EIRs.

www.PharmCast.com is the world leading website designedspecifically for pharmaceutical, clinical and biotechnologyprofessionals. www.PharmCast.com brings up-to-date

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BioResearch Monitoring Alert, is the monthlypublication that analyzes 483s and Establishment

Inspection Reports (EIRs) for FDA inspections of clinical investigators, institutionalreview boards (IRBs), sponsor/monitors, contract research organizations (CROs) andtesting labs (GLP). This is the first publication devoted exclusively to analyzing"BiMo" inspection records. Look inside for examples of the kind of articles you'll readeach month! Visit http://www.fdainfo.com/bioresearch/index.html for more info.

TO REGISTER CALL 1-800-882-8684 OR VISIT US AT WW

W.IQPC.COM

November 14-16, 2005 •

Sheraton Society Hill Hotel •Philadelphia, PA

•Johnson & Johnson

utilizes Six Sigma m

ethodology without formal training

•Alcon Laboratories

practices Continuous Improvem

ent initiatives•

Hoffmann-La Roche

integrates Risk-Based methodology in pharm

aceuticalprocess validation strategy

•Johnson & Johnson

utilizes strategic planning for quality•

Adolor Corporationm

anages change control effectively•

Hoffmann-La Roche

benefits from application of Failure M

ode and EffectsAnalysis in pharm

aceutical packaging•

Abbott Laboratoriesunderstands and utilizes risk analysis tools

And many m

ore...

Hear Industry Case Studies and Gain Practical Knowledge on How:

Present the 5th Annual

Early Bird Discounts Available!See page 7 for more information

First 10 registrants receive acom

plimentary copy of Six Sigm

a forBusiness Excellence, w

ritten byconference speaker Penelope Przekop,Director of Global Quality M

anagement

at JOHN

SON &

JOHN

SON (J&

J)

FDA

Quality

System

s andS

IX S

IGM

A

for Pharmaceuticals and Biotechnology

REGISTER TODAY! CALL 1-800-882-8684 OR VISIT ONLINE AT WWW.IQPC.COM/PHARMAIQ

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2049.05/D/JN

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❑ Conference Plus All Workshops❑ Conference Plus Four Workshops........... ❑ A ❑ B ❑ C ❑ D ❑ E❑ Conference Plus Three Workshops ......... ❑ A ❑ B ❑ C ❑ D ❑ E❑ Conference Plus Two Workshops............ ❑ A ❑ B ❑ C ❑ D ❑ E❑ Conference Plus One Workshop ............. ❑ A ❑ B ❑ C ❑ D ❑ E ❑ Conference Only ❑ Workshop(s) Only ................................. ❑ A ❑ B ❑ C ❑ D ❑ E

See Page 5 for pricing details.