FDA Quality Systems and SIX SIGMA


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FDA Quality Systems and SIX SIGMA

  1. 1. Early Bird Discounts Available! See page 7 for more information Present the 5th Annual FDA Quality Systems and SIX SIGMA for Pharmaceuticals and Biotechnology November 14-16, 2005 • Sheraton Society Hill Hotel • Philadelphia, PA Our Distinguished Faculty Includes: Rowland A. Yovonie, PhD; PE John Gallardo Stan Mastrangelo Certified Six Sigma Black Belt Senior Quality Engineer Director, Information and Policy, Medical Devices, Group Leader, Quality Engineering & Statistical Group HOFFMAN-LA ROCHE, INC. Corporate and Regulatory Standards HOFFMANN-LA ROCHE, INC. ABBOTT LABORATORIES Jinus Moghbeli Dr. Ronald D. Snee Senior Manager David Dills Principal, Process and Organizational Excellence Corporate Quality Director of FDA Regulatory Compliance and Validation Services TUNNELL CONSULTING AMGEN FOCUS CVS David M. Stephon John Wilmoth Joseph P. Ceresa Vice President, Quality Assurance Production Project Manager Senior Auditor, Quality Operations ADOLOR CORPORATION ALCON LABORATORIES WYETH PHARMACEUTICALS Hear Industry Case Studies and Gain Practical Knowledge on How: First 10 registrants receive a complimentary copy of Six Sigma for • Johnson & Johnson utilizes Six Sigma methodology without formal training Business Excellence, written by conference speaker Penelope Przekop, • Alcon Laboratories practices Continuous Improvement initiatives Director of Global Quality Management • Hoffmann-La Roche integrates Risk-Based methodology in pharmaceutical at JOHNSON & JOHNSON (J&J) 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 tools And many more... Media Partners; TO REGISTER CALL 1-800-882-8684 OR VISIT US AT WWW.IQPC.COM
  2. 2. Pre-Conference Workshops MONDAY, NOVEMBER 14, 2005 A 8:00am – 11:00am Applying Lean Manufacturing to Your Organization’s Process Excellence Program in the Pharmaceutical and Biotech Industry Many organizations have embraced the continuous • Lean deployment challenges for process driven and consumer industries providing guidance, training improvement programs such as TQM and Six Sigma industries and deployment services . Prior to his current position, through the development of a formalized Process • How to identify and define the Value Stream Mr. Chatterjee was Vice President, Pharmaceutical Excellence program. Lean manufacturing is Quality • Tools for optimizing the Value Stream and how to Operations for Aradigm Corporation where was philosophy that can greatly strengthen the apply them responsible for establishing their process development, effectiveness of an organizations process excellence • How to deploy "Kaizen teams" and how to achieve engineering, validation, facilities and manufacturing initiative. Lean manufacturing concentrates on breakthrough improvements capabilities. He also served as Plant Manager for minimizing the consumption of resources that adds • Metrics for describing a lean organization Boehringer-Mannheim's disposable coagulation testing no value to the finished product. This is achieved by division. Mr. Chatterjee is a Six Sigma Master Black optimizing those processes that bring value to your About Your Workshop Leader: Belt and has extensive experience in the design and product thereby eliminating wasted time, money, and Bikash Chatterjee is the Chief Operating Officer of implementation of quality systems and has productivity. Topics covered in this workshop include: Pharmatech Associates Inc., a full service consulting firm implemented Six Sigma and Lean manufacturing • Differences between Six Sigma and Lean Manufacturing servicing the pharmaceutical, medical device/diagnostic solutions in the pharmaceutical industry. B 11:15am – 2:15pm Black Belt Not Required: Six Sigma for the Functional Manager Luncheon will be served during this workshop. Have you heard the strong message that in order to Key concepts include: role, Ms. Przekop is responsible for BRM controlled create the cultural change needed for full • Process Focus documents, quality and compliance metrics, and implementation of a Quality Management Approach, • Customer Focus & Collaboration Corrective Action Plan (CAP) management. In high-level support is essential? Are you interested in • Data Driven Management addition, she serves as the key BRM liaison with J&J implementing Six Sigma, ISO 9000:2000 and/or • Strategic Planning for Quality Quality Assurance and authored the J&J Primer for Malcolm Balridge concepts but don't have a black belt? This workshop provides attendees with the Drug Safety Compliance. Prior to joining J&J, Ms. Don't know how to get one? Can't get one? Or have other strategic context for implementing a Six Sigma- Przekop held positions of increasing Quality priorities? Here's the answer: There are ways that related program that reflects the goals of the Management-related responsibilities at Hoechst middle management can incorporate key Quality company as well as the specific imperatives of their Celanese, Novartis, Wyeth, and Covance, a Contract Management concepts in its processes. No longer do personal organization, whether it consists of two Research Organization, as well as consulting you have to wait until corporate decides that Six Sigma people or over a hundred people. assignments with Pfizer and Rhone-Poulenc. Ms. is the answer, brings in consultants or starts a Black Belt Przekop is an American Society for Quality (ASQ) training program. This workshop focuses on how you can About Your Workshop Leader: Certified Quality Manager. Her book, Six Sigma for begin making a difference in your organization today. Penelope Przekop, MSQA, is currently the Director of Business Excellence: A Manager's Guide to Supervising Global Quality Management for the Johnson & Johnson Six Sigma Projects and Teams, McGraw-Hill, became (J&J) Benefit Risk Management (BRM) organization. In her available in bookstores everywhere in September 2005. C 2:30pm – 5:30pm Utilizing a Holistic Approach to Performance Improvement The pharmaceutical industry, like many other a holistic approach that integrates the useful tools About Your Workshop Facilitator: industries, is experiencing a growing need to improve from all approaches into a common methodology. A Dr. Ronald D. Snee is Principal, Process and its performance. Regulatory compliance issues, holistic approach to improvement is the subject of Organizational Excellence at Tunnell Consulting. He quality problems, side effects of drugs, the need to this workshop. Emphasis is on: has an outstanding record of leadership in process reduce costs; the list of problems is getting longer. • Deciding what tools to use on what kind of and organizational improvement in a wide range of How to go about this improvement in a systematic problems. industries, including pharmaceuticals, food, and focused manner is the question. Fortunately a • A problem solving and process improvement chemicals, telecommunications, insurance, financial world-class body of improvement technology exists methodology services, newspapers and clinical diagnostics. Dr. known as Six Sigma. There are other effective • Making effective use of improvement methods Snee is an American Society for Quality Shewhart improvement methods used in the pharmaceutical when an organization is not engaged in a top-down and Grant Medallist and a Fellow of ASQ and the industry such as Lean manufacturing and Process organization-wide improvement initiative American Statistical Association. He has published Analytical Technology that reduce the risk of non- • Sustaining the gains of improvement projects more than 155 articles and coauthored 2 books on compliance to Good Manufacturing Practices. This • Using improvement to drive organizational culture Six Sigma with Roger W. Hoerl of General Electric often results in a lot of non-productive discussion change entitled Leading Six Sigma – A Step-by-Step Guide about which improvement approach to use in a given • Pharmaceutical applications which include diverse Based on Experience at GE and Other Six Sigma situation. The prudent person uses all these areas such as yield improvement, deviation reduction, Companies and Six Sigma Beyond the Factory Floor - approaches, selecting the right tools for the problem batch record release, quality systems improvement, Deployment Strategies for Financial Services, at hand. To implement such a philosophy one needs clinical development and technology transfer. Healthcare and the Rest of the Real Economy D 5:45pm – 8:30pm Special Cause Differential Diagnosis Problem Analysis Dinner will be included during this workshop This workshop presents CAPA-compliant techniques audience participation. Topics covered include: Compliance and Manufacturing issues. Mr. Speir has for gathering, organizing, and analyzing manufacturing, • Understanding special cause differential diagnosis spent the last ten years applying Kepner-Tregoe's lab, and quality data into timely, logical, problem analysis Problem Solving, Decision Making, Risk Analysis and comprehensive investigations suitable for internal use • Applying special cause techniques to common Project Management processes to specific issues in and FDA review. Learn to conduct robust root cause cause process improvements manufacturing and cGMP CAPA processes for many analyses on unexpected discrepancies, to understand • Selecting appropriate corrective and preventive leading pharmaceutical firms. He has worked in the and eliminate recurring problems by selecting actions for process improvement pharmaceutical practices of Booz-Allen & Hamilton, PA appropriate corrective and preventive actions, and to • Implementing documentation techniques to Consulting and The Life Sciences Group. Mr. Speir is a document investigation data analysis effectively. We prevent FDA 483s, inspection findings, and frequent speaker at industry events and has published will discuss applications of the method to common warning letters articles on pharmaceutical quality and project cause "Six Sigma" style improvement efforts. management issues. About Your Workshop Facilitator: This workshop utilizes a case study and encourages Wade Speir, Senior Consultant, Kepner-Tregoe's Pharmaceutical Practice, specializes in Quality & 2 FDA QUALITY SYSTEMS AND SIX SIGMA FOR PHARMACEUTICALS AND BIOTECHNOLOGY
  3. 3. 11:30 Surviving an FDA Audit: Thinking Like an FDA DAYONE Tuesday, November 15, 2005 Officer-CASE STUDIES As the backbone for every company or facility, your CAPA program is an integral part of your organization’s functionality and CAPA programs are known as the immune system to determine how healthy or unhealthy the business unit. Moreover, the FDA is 7:30 Continental Breakfast and Registration watching. But how can you prove to the FDA that you are in control and in compliance? This session addresses issues with CAPA programs and defines critical 8:30 Welcome Address and Opening Remarks from the considerations you must know when planning and preparing for an FDA audit. Some of the activities associated with developing, deploying and implementing a CAPA Conference Director and Conference Chairperson system includes collect information, analyze information, identify an investigate Sapna Mehta product and quality problems, and take appropriate and effective corrective and//or Conference Director, PharmaIQ preventive action to prevent their recurrence. Utilizing real-life issues and case IQPC studies, this session sparks interactive discussions with an industry leader who is Rowland A. Yovonie, PhD; PE ready to share his perspectives with you. Topics addressed include: • What the FDA looks for in your CAPA program, documentation red flags and trigger points Certified Six Sigma Black Belt, Group Leader, Quality Engineering & • Examining common FDA reasons for the 483 and warning letter and addressing best practices Statistical Group, HOFFMANN-LA ROCHE, INC. • Conducting a risk-based assessment for your facility and Conference Chairperson • Preparing for an FDA audit and inspection - preparing and managing the audit/inspection process 8:45 Continuous Improvement Initiatives: Secure the Future! • Remediation tactics and strategies In this session, our speaker guides the audience through the steps for David Dills implementing a continuous improvement initiative in your organization. He provides Director of FDA Regulatory Compliance and Validation Services an overview of a Continuous Improvement program structure and discusses how to FOCUS CVS obtain senior management buy-in and support. Other topics include: • Methods to get employee participation at all levels of the organization 12:45 Luncheon for Speakers and Attendees • How to recognize and reward employees for their participation • Overview of Lean Manufacturing and Six Sigma 1:45 Risk Management in a Regulated Industry • Methods to "brainstorm" ideas for continuous improvement projects This session will focus on the fundamental premise of risk management as it John Wilmoth applies to the regulated industry. With the new initiatives on process and productivity Production Project Manager improvement ideas such as six-sigma, managers in a regulated industry are often ALCON LABORATORIES required to shift their paradigms. This session discusses how six-sigma processes and lean thinking can effectively integrate the principles of risk management and ensure 9:30 Integrating Risk-Based Methodology in Pharmaceutical quality and compliance. Process Validation Strategy Shamik Pandit The Pharmaceutical Industry has not yet fully integrated a risk-based methodology into President Process Validation Strategy. The 1987 industry guideline on Process Validation requires GMP SCIENTIFIC, INC. that all processes need to be validated. Process understanding and associated risk are not explicitly stated in the guideline. For Process Validation to be customer focused, reliable, 3:00 Application of Failure Mode and Effects Analysis in and cost effective, risk management must be an integral part of the overall Process Pharmaceutical Packaging Validation Strategy. This is particularly important in the emerging process technologies in In this session, the speaker will provide an overview of the purpose and benefits Pharmaceutical Manufacturing, where product failure can be caused by the failure of the of an FMEA and further discuss a successful case study using this risk analysis tool manufacturing process. for evaluation of a packaging process in response to customer complaints. Key This presentation will discuss the conceptual differences amongst the 1987 Topics include: Pharmaceutical Process Validation guideline, 1999 Global Harmonization Task Force, • What is an FMEA FDA 1997 Quality System Requirements for Medical Devices, and FDA 2004 cGMP • Types of FMEA Guidelines (Guidance?) for the 21st Century. The presentation covers: • Benefits of FMEA • Comparison of Pharmaceutical and Medical Device Industry Process Validation Guidelines • When to use FMEA • Verification, Qualification, and Validation • FMEA Process • The rationale for applying a risk assessment • Elements of an Effective FMEA Process • What is a Risk-Based Methodology? • Packaging Process FMEA - Case Study • Why use a Risk-Based Methodology? John Gallardo • How to implement a Risk-Based Methodology Senior Quality Engineer Rowland A. Yovonie, PhD; PE HOFFMANN-LA ROCHE, INC. Certified Six Sigma Black Belt, Group Leader, Quality Engineering & Statistical Group HOFFMANN-LA ROCHE, INC. 3:45 Applying Lean Principles to Your Six Sigma Initiatives Separately, Lean and Six Sigma have changed the face of the pharmaceutical 10:15 Morning Refreshment and Networking Break business. Together, they become an important tool for improving product and process quality, production efficiency, and across-the-board profitability. Lean Six Sigma 10:45 Managing Change Control Effectively introduces today's most dynamic program for streamlining the performance of both • Methods to maintain a state of control despite ever-changing demands the production department and back office, providing with the cost reduction and • Change control concepts and regulatory requirements quality improvements to stay one step ahead of competitors. Pharmaceutical • Ideas for improving your existing change control SOPs and forms companies are now starting to realize the impact of how both lean principles and six • Recognition of items that MUST be on your change control forms sigma processes could have on the success of their business. This panel discussion • Create, review, approve, distribute and store change documents will include core concepts on Lean and Six Sigma. • Coordinate changes that cross multi-departmental boundaries Panel Facilitator and Chairperson: • Meet FDA and other regulatory authorities change control requirements with proof Rowland A. Yovonie, PhD; PE, Certified Six Sigma Black Belt of compliant, well-managed changes HOFFMANN-LA ROCHE, INC. • Respond to emergency or temporary changes • Documenting change justifications Panel Members: • Follow up and closure to implemented changes Bikash Chatterjee, Chief Operating Officer, PHARMATECH ASSOCIATES, INC. David M. Stephon John Wilmoth, Production Project Manager, ALCON LABORATORIES Vice President, Quality Assurance ADOLOR CORPORATION 4:30 Day One Concludes Mid-Conference Workshop TUESDAY, NOVEMBER 15, 2005 E 4:45pm – 7:45pm Maximizing Your Operational Excellence Program Dinner will be included during Workshop With the current pharmaceutical industry financial also review an example study that can be used to justify currently active with the Emerson Operational Excellence pressures, it has become increasingly important to managing batch records in an electronic, paperless consulting program. develop solid programs that positively impact the bottom environment. Examples of several tools will be included line. In order to develop an effective operational in the workshop. Christopher P. Amstutz is the Director of Software Quality excellence program, particularly one with a Six Sigma Assurance at Decision Management International in focus, several key aspects of the program must carefully About your Workshop Facilitators Bradenton, FL. Christopher has 6 years of be developed. Key aspects that will be discussed in this Michalle Adkins is a Sr. Principal Engineer in the Life pharmaceutical industry experience in compliance, workshop include: defining areas of opportunity, Sciences Industry Center at Emerson Process Management implementation, and computer system validation. In measuring and collecting validated data, analyzing the in Royersford, PA. Michalle has 13 years of addition to Quality Assurance work, he has participated data with respect to the particular processes, moving pharmaceutical industry experience in engineering, in Emerson Operational Excellence consulting program. forward with improving your processes, and controlling automation support, computer validation, production, that improved performance. In this workshop we will and planning. In addition to project work, she is also 3 TO REGISTER, CALL 1-800-882-8684 OR VISIT US ONLINE AT WWW.IQPC.COM/PHARMAIQ
  4. 4. 11:45 Conducting Effective Audits of Your Internal Systems DAYTWO Wednesday November 16, 2005 How does FDA’s quality system approach impact the way to conduct an internal audit of your facility? By understanding FDA Guidance Documents: “Drug Manufacturing Inspections, Program 7356.002”; and “cGMPs for the 21st Century: A Risk Based Approach”, this session explores what is necessary to 7:30 Continental Breakfast manage your audits using the quality systems. Key topics include: • Audit program goals 8:30 Recap of Day One from the Conference Chairperson • Developing strategies for inspecting the process Rowland A. Yovonie, PhD; PE • Relationship management during an audit Certified Six Sigma Black Belt • Communication by Auditors Group Leader, Quality Engineering & Statistical Group Joseph P. Ceresa HOFFMANN-LA ROCHE, INC. Senior Auditor, Quality Operations WYETH PHARMACEUTICALS 8:45 Strategic Planning for Quality: Applying Six Sigma in the Trenches [Keynote Speaker] 12:15 Luncheon for Speakers and Attendees Despite what you may have heard, middle management can implement the underlying concepts of Six Sigma in the day-to-day. To do this, managers must first understand the concepts, believe in them, and create a strategy that weaves them into 1:30 Quality Agreements the culture of their personal organizations. In this session, managers of all levels will In this era of lean manufacturing, rapid pharmaceutical product development and learn how to improve the quality of their organizational outputs by: global clinical trials, companies are utilizing contract manufacturing organizations • Creating a management framework (and standing behind it) (CMO) to facilitate the process. Once the decision has been made to use the • Organizing their organizations for quality (no matter what the size) services of a CMO, the sponsor who holds the Investigational or Marketing • Following the DMAIC cycle for their organizations (only as appropriate) Application (e.g., IND, CTA, CTX, NDA, BLA, MAA, ANDA) for the drug product, • Continuously monitoring and improving their organizations (maintain the momentum) biological product or medical device is responsible for ensuring current Good Penelope Przekop, MSQA Manufacturing Practice (cGMP) compliance. One means of documenting Head, Global Quality Management compliance requirements for both the sponsor and the contracted organization is JOHNSON & JOHNSON (J&J) the Quality Agreement. This session will discuss the following aspects of the Quality Agreement to ensure manufacturing compliance: 9:45 Quality Systems at Amgen, from Development to Deployment • Rationale for the Quality Agreement Drug, pharmaceutical and biologics manufacturing firms are increasingly being audited • Responsibilities for writing, reviewing and approving under a quality systems approach. In addition, Sept 29, 2004 FDA Guidance for Industry, • Regulatory requirements Quality Systems Approach to Pharmaceutical current Good manufacturing regulations, • Quality Agreement format and content emphasizes the importance of the Quality Systems, Risk based approach and Quality by • Managing changes to the Quality Agreement Design. This presentation describes Amgen’s proactive approach to Quality Management • Role of the Quality function to ensure adherence to the Quality Agreement System and striving to be “Best in class” with the following elements: Felicia Ford-Rice, M. Mgmt, RAC • Being proactive, recognizing the need and obtaining senior management support Director of Quality Assurance • Conducting a business evaluation ACAMBIS, INC. • Developing a strategy and Quality Plan • Communication and pilot 2:45 Developing a Simplified Change Control System for Your • Execution and deployment Quality System and Utilizing Six Sigma Principles • Measurement, Continuous improvement and Maintenance It is well-known throughout the pharmaceutical and biotechnology industries that Jinus Moghbeli Change Control is necessary for ensuring compliance with FDA regulations. It is up to Senior Manager pharmaceutical companies to develop effective systems that successfully manage and Corporate Quality AMGEN track change. One of the greatest challenges that people who practice change control are struggling with today is dealing with the complicated nature of how many systems 10:30 Morning Refreshment Break are built. Often, this complexity results in people avoiding the system altogether, ultimately defeating the purpose of the system in place. This session instructs 11:00 Understanding Risk for the Pharmaceutical Industry attendees on what is needed to build a formal Change Control system and how this Since FDA went public with their initiative for Pharmaceutical cGMPs for the 21st system can be simplified with fewer requirements. Key points discussed include: Century, "risk" has become one of the most used, and misunderstood, terms in the • Definition of a Change Control system industry. Companies that manufacture devices and drugs have a fundamental • System criteria and requirements understanding of risk analysis tools like FMEA and HACCP, but what does FDA mean • Six Sigma principles as it applies to Quality System when they talk about "risk management" and how does that differ from "risk analysis"? • Creating and using Change Control forms related to compliance and documentation Key topics include: • Effectively applying a simplified system • A brief history of risk science • Post-implementation • General principles and tools of risk analysis Suggy Chrai • Preparing for FDA’s risk management initiatives-inspections, submissions, quality President and CEO systems CHRAI ASSOCIATES, INC. • Summary of recent FDA activities-guidances, regulatory activity, presentations Stan Mastrangelo Director, Information and Policy, Medical Devices, Corporate and Regulatory Standards 4:00 Closing Remarks and Conference Concludes ABBOTT LABORATORIES Media Partners ProcessDevelopment.net is the main MarketResearch.com is the leading American Pharmaceutical Review is the leading web information portal dedicated to provider of global business quarterly review of business and technology for the chemical process R&D. Updated on a regular basis, the intelligence on markets, industries, and companies. We pharmaceutical industry throughout North unique mix of exclusive interviews, specialist supplier help professionals stay ahead of market developments and America. Each issue offers American Pharmaceutical Review's listings, events, news and new products makes this a one- trends with expert data and analysis. See how we can 30,000 readers unbiased editorial on the following topics: stop-shop for essential information. For reference there help you make better decisions today. Visit materials, information technology, research & development, are links to research centres, journals, books, reviews and MarketResearch.com or call 1-800-298-5699 to speak analytical development and control, equipment and facility market reports. with a research specialist. FDA Quality: manufacturing, regulatory affairs and outsourcing. http://www.marketresearch.com/redirect.asp?progid=5313 www.americanpharmaceuticalreview.com Published by Espicom Business Intelligence, Published by Espicom Business Intelligence, World Pharmaceutical Markets provides a American Pharmaceutical Outsourcing is a bimonthly Pharmaceutical Companies Analysis (PCA) complete and detailed review of over 60 key provides a complete and detailed review of journal dedicated to pharmaceutical and pharmaceutical markets around the globe. Each report over 40 of the world’s major pharmaceutical companies. biopharmaceutical contract services. Each issue provides an insightful interpretation of market trends and Each report provides a full review of the company’s reaches over 12,000 key decision makers involved in clinical a range of information from economic/demographic data activities, from its origins to its latest corporate activity, research, regulatory affairs and the outsourcing of contract through to health status, services, personnel and funding including mergers and acquisitions, agreements, services in the pharmaceutical and biopharmaceutical industries to regulation and domestic production. In addition to this divestitures, major purchasing contracts and litigation. in North America. For your FREE subscription, please fill out our all country reports now include unique and original 5-year Sections are included on products, international activities on-line form at www.americanpharmaceuticaloutsourcing.com market forecasts - all in one convenient, monthly updated and R&D, as well as a full, in-depth five year financial ➔ service. To start your subscription online or to download analysis. To start your subscription online or to download further information, go to www.espicom.com/wpm further information visit www.espicom.com/pca Continued on next page 4 FDA QUALITY SYSTEMS AND SIX SIGMA FOR PHARMACEUTICALS AND BIOTECHNOLOGY
  5. 5. Media Partners continued... Get Warning Letter Bulletin is www.PharmCast.com is the world leading website designed news the only service that specifically for pharmaceutical, clinical and biotechnology and analysis of GMP validation issues, summarizes all warning and professionals. www.PharmCast.com brings up-to-date including software, computer and untitled letters, categorized by YOUR INDUSTRY. Every information on pharmaceutical patents, FDA, news, jobs and Buyer's Guide to its process validation, with a subscription two weeks you can read summaries of all warning and visitors. It was created and is maintained by pharmaceutical and biotechnology to Validation Times. Examine FDA untitled letters, learn what FDA found on its inspections, professionals. Visit www.PharmCast.com and discover for yourself why it is so popular inspection reports for key validation and read company responses! among professionals. citations. Validation Times also comes with a weekly email news alert FDA Inspection Monitor is the BioResearch Monitoring Alert, is the monthly compliance and enforcement news. only newsletter with the publication that analyzes 483s and Establishment Visit www.FDAINFO.com for more strategic information you need about FDA inspections, Inspection Reports (EIRs) for FDA inspections of clinical investigators, institutional information or contact us at including what FDA inspectors are really looking for, how review boards (IRBs), sponsor/monitors, contract research organizations (CROs) and (800) 776-5105 or (703) 779-8777, companies are responding to 483 and EIR citations, which testing labs (GLP). This is the first publication devoted exclusively to analyzing E-mail: service@fdainfo.com. companies are targeted for enforcement proceedings and "BiMo" inspection records. Look inside for examples of the kind of articles you'll read who's making FOIA requests for FDA 483s and EIRs. each month! Visit http://www.fdainfo.com/bioresearch/index.html for more info. SPONSORSHIP and EXHIBIT OPPORTUNITIES LODGING INFORMATION Sponsorships and Exhibits are excellent opportunities for your company to showcase Sessions for the Conference and Workshops will its products and services to high-level, targeted decision makers attending the FDA be held at: Quality Systems and SIX SIGMA for Pharmaceuticals and Biotechnology. PharmaIQ and its FDA Quality Systems and SIX SIGMA for Pharmaceuticals and Biotechnology Sheraton Society Hill Hotel conference helps companies like yours achieve sales, marketing and branding 1 Dock Street, Philadelphia, PA 19106 objectives by setting aside a limited number of event sponsorships and exhibit Phone: 215-238-6000 • Fax: 215-238-6652 spaces - all of which are custom-tailored to help your company create a platform to maximize its exposure at the event. To secure reduced rates, please contact the hotel at least four weeks prior to the conference and be sure to mention the conference name. For more information on Sponsoring or Exhibiting at FDA Quality Systems and SIX SIGMA for Pharmaceuticals and Biotechnology, please contact Shannon Forrester at 1-212-885-2719 or via email at sponsorship@iqpc.com. Note: Contact hotel for direction and transportation suggestions. Here’s what Past Attendees had to Say "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 REGISTER BY PHONE, FAX, E-MAIL OR WEB SITE Web: www.IQPC.com/pharmaIQ Details for making payment via EFT or wire transfer: JPMorgan Chase Phone: 1-800-882-8684 or 973-256-0211 Penton Learning Systems LLC dba IQPC: 957-097239 ABA/Routing #: 021000021 Fax: 973-256-0205 24 Hours A Day Reference: Please include the name of the attendee(s) and the event number: 2049.05 Mail: International Quality & Productivity Center Payment Policy: Payment is due in full at the time of registration and includes lunches, refreshment and detailed conference materials. 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As such, IQPC reserves the right to alter or modify the advertised speakers and/or topics if necessary. Any substitutions or alterations will Silver Package Save $200 Save $100 $2,528 be updated on our web page as soon as possible. Conference Plus 1 Workshop $2,328 $2,428 Please note that speakers and topics were confirmed at the time of publishing, however, Conference Only Save $100 circumstances beyond the control of the organizers may necessitate substitutions, alterations $1,899 $1,999 $1,999 or cancellations of the speakers and/or topics. As such, IQPC reserves the right to alter or modify the advertised speakers and/or topics if necessary. Any substitutions or alterations will Vendor Pricing: Add $300 Service Fee be updated on our web pages as soon as possible. Team Discounts! For information on team discounts, please contact IQPC Customer If you have a dietary restriction, please contact our Customer Service Department at 1-800- Service at 1-800-882-8684. 882-8684 to discuss your specific needs. FDA and government employees are eligible for other savings, please contact Customer Service 2005 IQPC. All Rights Reserved. The format, design, content and arrangement of this at 1-800-882-8684 for further details. Valid ID must be presented on-site at the conference. brochure constitute a trademark of IQPC. Unauthorized reproduction will be actionable under Note: One form of discount is available per registrant. the Lanham Act and common law principles. 5 TO REGISTER, CALL 1-800-882-8684 OR VISIT US ONLINE AT WWW.IQPC.COM/PHARMAIQ
  6. 6. International Quality & Productivity Center REGISTRATION CARD 535 5th Avenue, 8th Floor New York, NY 10017 ❑ YES! Please Register me for FDA Quality Systems and SIX SIGMA for Pharmaceuticals and Biotechnology ❑ 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. Your product code is: When registering by phone, please provide the priority code above. Name __________________________________________________________________ Title ___________________________________________________________________ Organization ____________________________________________________________ Address _______________________________________________________________ City ______________________________ State ______ Zipcode ________________ Phone ____________________________ Fax______________________________ E-Mail _________________________________________________________________ ❑ Please keep me informed via email about this and other related events. Web: www.iqpc.com/pharmaIQ ❑ Check enclosed for $_____________________(Payable in U.S. Dollars to IQPC) Phone: 800-882-8684 ❑ Charge ❑ AMEX ❑ Visa ❑ Master Card 973-256-0211 Card #_____________________________________________ Exp Date:_____/_______ Fax: 973-256-0205 Details for making payment via EFT or wire transfer can be found on preceding page. E-Mail: info@iqpc.com 2049.05/D/JN ❑ I cannot attend, but please keep me informed of all future events. REGISTER TODAY! CALL 1-800-882-8684 OR VISIT ONLINE AT WWW.IQPC.COM/PHARMAIQ TO REGISTER CALL 1-800-882-8684 OR VISIT US AT WWW.IQPC.COM Systems and FDA Quality Hear Industry Case Studies and Gain Practical Knowledge on How: November 14-16, 2005 • Sheraton Society Hill Hotel • Philadelphia, PA And many more... • Abbott Laboratories understands and utilizes risk analysis tools • Hoffmann-La Roche benefits from application of Failure Mode and Effects • Adolor Corporation manages change control effectively • Johnson & Johnson utilizes strategic planning for quality • Hoffmann-La Roche integrates Risk-Based methodology in pharmaceutical • Alcon Laboratories practices Continuous Improvement initiatives • Johnson & Johnson utilizes Six Sigma methodology without formal training Analysis in pharmaceutical packaging process validation strategy at JOHNSON & JOHNSON (J&J) Director of Global Quality Management conference speaker Penelope Przekop, Business Excellence, written by complimentary copy of Six Sigma for First 10 registrants receive a for Pharmaceuticals and Biotechnology SIX SIGMA Present the 5th Annual See page 7 for more information Early Bird Discounts Available!