SEPTEMBER 2005What: Global Pharma Manufacturing Summit
When: September 8-9
Where: Marriotts Evergreen Conference Resort, Atlanta, Ga. Description: The pharmaceutical manufacturing industry is an industry under pressure. Pressure to innovate and streamline manufacturing operations, reduce cost and time to market whilst meeting compliance and regulatory standards. The world's top pharmaceutical manufacturing professionals will meet at the Global Pharma Manufacturing Summit to discuss the issues that they are focusing on today, including lean-manufacturing, MES, outsourcing manufacturing and implementing successful technology transfers.Speakers include:
- A Multi-Scale Perspective on PAT -- Charles Cooney, Co-Director, Sloan Pharmaceutical Program, MIT
- Approaches to the Acquisition &Amp; Management of Regulatory Information Under FDAs 21st Century Quality Initiatives -- Dhiren Shah, Director CMC US Regulatory Affairs, Aventis
- The Quest For Excellence In Pharmaceutical Manufacturing, Industry Perspectives on Quality 21st Century Initiatives -- Eilleen Morrissey, VP Global Operational Excellence, Merck
- Protecting the Ever-Complex Supply Chain, A Global Regulatory Perspective -- Eshetu Wondemagegnehu, Technical Officer and Focal Person, for Counterfeit Drugs, World Health Organization
- "Anti-Counterfeit Solution -- Use of EPC Global Standards" -- John Roberts, Director, Healthcare, Uniform Code Council
- Future Implications of PAT -- Dr. Melvin Koch, Director, Center for Process Analytical Chemistry, University of Washington
- Science-Based Project Management & PAT -- Dr. Stephen Byrn, Head, Department of Industrial & Physical Pharmacy, Purdue
Contact: Stewart Press, Executive Vice President
World Trade Group (North America) Inc.
20 Toronto Street, Suite 900
Toronto, ON M5C 2B8
T: 1 416 214 3400
F: 1 416 214 3403
[email protected]
When: September 8-9
Where: Los Angeles area (call for details)
Description: "Formulating for Nutritional Supplements" is a new two-day introductory course on formulating nutritional supplement tablets and capsules. This course is engineered from the bottom up for new formulators, nutritionists now formulating products and new or small business owners looking for formulating information in a basic, fast course. The graduate will both pass an open-book written examination and successfully construct a nutritional supplement formula before being certified.Contact: Solid Dosage Training Inc.497 Phoenix CircleVallejo, Calif. 94589(925) 352-5724www.soliddosagetraining.comWhat: Conformia's Scale-Up Optimization Quarterly Breakfast Seminar
When: September 9
Where: Hyatt Regency, Princeton, N.J.Description: This seminar is focused on exploring current events and issues facing Pharmaceutical Process Development arena.Our inaugural event will be chaired by Ken Morris along with Ajaz Hussain from the FDA's Office of Pharmaceutical Sciences. The program topic "Optimizing Pharmaceutical Development: Implementing ICH Q8 Guidelines for Better Process Understanding" will allow development chemists and engineers the opportunity to learn how they can incorporate the principles and objectives outlined in ICH Q8 to improve their development operations. Specifically, this interactive session will allow attendees the opportunity to discuss what organizations should consider when designing chemical and/or bio routes as well as the supporting scale-up business and information processes needed to ensure alignment with the ICH guidelines. Issues of risk-management, specifications, operating parameters, and design requirements for scale-up as a product evolves across the development lifecycle will be explored and discussed.The talks will be followed with a real-life case study detailing how a Top 10 Pharmaceutical Company was able to build and define its design space by getting control of its information management capabilities. The presentation will detail how the company was able to leverage information into a framework of effective knowledge management one that served as a catalyst for achieving the benefits of implementing an optimal design space. The case will be particularly useful for those executives whose organization's Process Understanding initiatives are hampered by lack of adequate business processes and/or supporting information management capabilities.The seminar will close with a panel discussion entitled "From Concept to Practice: Prescription for Implementing ICH Q8 and Process Understanding Concepts in Industry."Space is limited so register early! If you are interested in participating in this event, please RSVP by August 25, 2005.Contact: Phone: 781-593-7244. E-mail: [email protected]; website: www.conformia.com/news/events/rsvp09082005.htmlWhat: SAP's RFID & Manufacturing Compliance Summit
When: September 12
Where: Millenium Broadway Hotel, New York City.Description: Learn how life sciences companies are achieving RFID and manufacturing compliance. Co-sponsored by SAP, HP, Zebra and Nokia, the summit examines solutions to help life sciences firms:
- Manufacture products that meet quality, safety and compliance requirements, and document all process changes;
- Compress clinical supply chain cycles and improve the scale-up process from clinical to commercial manufacturing;
- Create electronic tracking mechanisms for greater supply chain security and patient protection against counterfeit drugs;
- Leverage lean manufacturing principles to improve operations;
- Address FDA RFID guidelines and state ePedigree requirements to ensure product authenticity, safety and integrity.
When: September 14-15, 9 a.m. to 4 p.m.
Where: Uhlmann's U.S. headquarters, Towaco, N.J.Description: Featuring presentations from leading industry experts and representatives from major pharmaceutical companies, the event will cover such topics as: child-resistant safety features; anti-counterfeiting; patient compliance; online printing; options for different materials; wallet packaging; in-line leak detection; and applications such as solid dose, powder, and liquids.The Blister Roundtable will also feature the U.S. debut of the worlds fastest thermoformer, the new Uhlmann B1880, with an output capability of 1300 blisters per minute.A luncheon will be served each day, and there will be an evening dinner cruise on Wednesday night.Contact: Diane Hands at 973-541-6288, or e-mail [email protected].What: ASQ's Fifth Annual Six Sigma Forum Roundtable
When: September 15-16
Where: Pier 66 Hyatt Regency, Fort Lauderdale, Fla.Description: This is an exclusive, two-day briefing and networking event designed by and for top-tier Six Sigma practitioners. To allow attendees more discussion time with presenters, registration is limited to 150.Attendees will be able to choose from multiple in-depth presentations by Six Sigma professionals employed in a variety of industries, who will discuss their experiences with different applications, attendees can attend networking sessions, keynotes, a panel discussion, and a gala reception, securing information and contacts useful in meeting their organizations Six Sigma initiatives.Additionally, the American Society for Quality Six Sigma Black Belt Certification Exam will be offered on-site Sept. 14, the day before the roundtable starts. Also new for 2005 is a pre-roundtable course, "Managing and Leading in a Six Sigma World," taught by George Gordon.Contact: Dan Vnuk, 414-298-8789, ext.7407 or [email protected].What: Workshop: The Magnesium Stearate Solution
When: September 22
Where: IMA, 211 Sinclair St., Bristol, Pa., 19007 USADescription: A practical, hands-on session in how to predictively determine the quality of your tablet by monitoring lubrication in real time with a PAT tool. The one-day event, co-sponsored by Mathis Instruments and IMA, provides attendees with a general overview of how to reduce lengthy set-up time of the tablet press, avoid wasted product and diminish failed dissolution tests by placing a window on the physical characteristics of your powder upstream. The workshop includes a wireless blending demonstration of the optimization of tablet press setup parameters in response to monitoring the lubrication of incoming batch material followed by compression and testing of the resulting tablets.This workshop has been constructed for those who are more interested in the practical applications of PAT tools vs. discussing the theoretical benefits. Specifically delivered for those tasked with introducing functional technologies to their organizations manufacturing operation in leveraging the window of opportunity the FDA has presented with the recent PAT Guidance. If you work in engineering, regulatory, QC/QA, manufacturing, or in the laboratory you will find this course to be extremely beneficial. Anyone involved in the optimization and control of lubrication and tablet press operation will find it valuable.Contact: Mathis Instruments Ltd.; telephone: 506-457-1515; toll-free 1-877-827-7623.What: Frontline Solutions Conference & Expo
When: Conference: September 26-28; Expo: September 27-29
Where: Navy Pier, ChicagoDescription: Frontline Solutions Conference & Expo is the world's largest industry forum focused on the application of Auto-ID and information management technologies and solutions, including radio frequency identification (RFID) technology. Frontline Solutions is focused on the needs of manufacturers in automotive, aerospace, healthcare, pharmaceutical, medical devices, food electronics, retail, consumer products and government.Keynote speakers include:
- Dr. Larry Lapide, Research Director, Center for Transportation & Logistics, Massachusetts Institute of Technology
- Ray Homan, Senior Vice President, SAP for High Tech
- Patrice Knight, Vice President, Business Transformation & Strategy, IBM Corp.
- Dr. Yossi Sheffi, Director, Center for Transportation and Logistics; Professor, Civil and Environmental Engineering; Professor, Engineering Systems Division, Massachusetts Institute of Technology
When: September 27-30
Where: Burlington Hotel, Dublin, IrelandDescription: In the ever-changing world of global regulation, the pharmaceutical industry needs to be able to meet the challenges that this presents every day of the week. This conference draws together industry and regulators from both sides of the Atlantic in order to discuss the latest developments that pharmaceutical companies need to keep up to date with.Contact: Mark Glynn, conference organizer; phone: +353 1 6051581 or visit the conference website.What: Malvern Diffraction Users Group Meeting
When: September 29
Where: Piscataway, N.J.Description: Malvern Mastersizer and Spraytec customers are invited to attend the first users group meeting organized in the U.S. Malvern technical experts will teach method development techniques, software tips and tricks, and data interpretation. International and American standards will be reviewed, including ISO 13320 and USP 429.Contact: Click here to register or call (508) 480-0200 ext. 230.What: The Next Generation of Biotech Patenting
When: September 29-30
Where: Marriott West India Quay Hotel, London, United Kingdom
Description: Now in its 11th year, this comprehensive two-day conference will ensure that you have all the information you need to understand and apply effectively the latest developments in pharmaceutical and biotech patent law and practice. Our highly distinguished panel of speakers, including Lord Justice Neuberger of the Court of Appeal of England and Wales, will impart their expert knowledge and provide you with the practical tools you need to deal with the latest case law, legislative developments, claims construction and execution.Key topics to be covered include:
- How to successfully prosecute and enforce complex biotech claims in Europe, U.S. and Japan
- The position of the EPO on Medical Use Claims, DNA sequences, stem cells, crystals and polymorphs
- The impact of developments in the Safe Harbour/Experimental Use Exemption on biotech patenting, including the Supreme Court decision on Merck KgaA v Integra Lifesciences I, Ltd.
- How to successfully obtain Supplementary Protection Certificates in fringe cases, such as a part of a kit
- Latest developments in the field of research tools and reach-through claims
- Latest judicial view on claim construction in Europe and the U.S.
- The challenges of prosecuting and enforcing patents in China
C5s Biotech Patenting feature an outstanding panel of speakers including representatives from Court of Appeal of England and Wales, EPO, Pfizer (U.S.), GlaxoSmithKline, Schering-Plough, Lorantis, Sigma-Tau, Intercell AG, De Clercq, Brant and Partners, Jones Day, D. Young & Co., Shusaku Yamamoto, Bird & Bird, Covington & Burlington, Ropes & Gray, Vossius & Partner, Cabinet REGIMBEAU, Townsend & Townsend, Hoiberg, Lovells, Kayscholar, Palmer & Dodge, Orrick
View the agenda and register online at: www.C5-Online.com/biopatenting/pr04
Contact: James Stackhouse on Tel: +44 (0) 20 7878 6929 or email: [email protected]
When: October 3-6
Where: Houston, TexasDescription: The program will include both brand-specific technology sessions and industry-focused sessions. The latter will address timely issues such as security, safety, compliance, and maximizing asset and business performance. Specific industry tracks will include Pulp & Paper, Food & Beverage; Pharmaceuticals & Fine Chemicals; Metals & Mining; and Water & Wastewater.Contact: Invensys Customer Visit Center, (508) 549-6500 or [email protected].What: IQPC's 3rd Annual Cold Chain Distribution for Pharmaceuticals Conference
When: October 17 20
Where: Pennsylvania Convention Center, Philadelphia, Pa.
Description: Attend this conference to learn the latest technology and best practices in cold chain distribution. Attendees will have opportunities to:
- Learn how to maintain an unbroken cold chain over longer distances.
- Hear 17 case studies on how the experts at top pharmaceutical companies improve their cold chain processes to reduce wastage, improve quality and increase customer satisfaction.
- Learn about the emerging technologies available that can revolutionize your cold chain approach.
- Choose from 10 workshops which explore practical solutions to various cold chain challenges.
- Meet and network with key subject matter experts and thought leaders.
- Gather important information on cutting edge technologies and suppliers.
- Take site tours to gain real-life experience on cold chain, supply chain and warehousing facilities.
- Customize their learning by choosing between 2 tracks based on their specific needs.
- Get to know the industry leaders in relaxed, informal cocktail receptions.
When: October 25 27
Where: McCormick Place Lakeside Center, Chicago, Ill.Description: North Americans #1 event for automation and control professionals is a catalyst for the exchange of information and ideas. ISA Expo 2005 features the latest and most extensive products and services exhibition, a strategically relevant technical conference, and a prominent continuing education and training program. With practitioners from over 70 countries, ISA Expo 2005 offers the most complete automation and control experience in todays marketplace.Contact: www.isa.org/isaexpo2005What: Pharmaceutical Manufacturing 2005
When: October 31-November 2, 2005
Where: Four Seasons Miami, Miami, Fla.Consider the rash of regulatory violations in 2004 a fair warning: FDA inspectors wont allow room for error in 2005. Pharmaceutical manufacturers need to implement new technologies and processes in an environment of stringent regulatory demands, increased competition and diminished profit margins. WBR's Pharmaceutical Manufacturing 2005 Conference addresses your most important, immediate critical issues to enable you to time and structure technology implementation, get on track with risk-based inspections and improve efficiencies of your manufacturing operation.Key Topics:
- Staying Ahead of Regulatory Developments: Balancing FDA Expectations with Shrinking Profit Margins
- Who is at Risk? Understanding the New Risk-Based Inspections, What it Means for Your Manufacturing Process and How to Stay Compliant
- Continuous Manufacturing Optimization: Maximizing Facility Use & Output to Benefit Your Bottom Line
- Implementing Successful PAT Initiatives Without Decimating Your Profit Margin
- Developing a cGMP Compliant Outsource Manufacturing Network From Contract to Validation
- RFID: Will the Early Bird Get the Worm? Timing RFID Implementation to Reap the Optimal ROI
- Gary duMoulin, Vice President, Quality Systems, Genzyme
- Hank Stern, Director, Manufacturing Supply Chain Support, Genentech
- James Tanguay, Ph.D., Vice President, Technical Operations, Kos Pharmaceuticals Biolex
- Robert Timko, CMC Group Director, AstraZeneca
- Martin Hynes, Ph.D., Director, Operations & Quality, Eli Lilly & Company
- George Heiler, Vice President, Manufacturing Operations, Zila
- Edward Branson, Vice President, Operations, Biolex
- Dietmar Wagenknecht, Senior Director, Technical Services, Astellas Pharma
- Jean-Marie Geoffroy, Ph.D., Director, Manufacturing Sciences, Abbott Laboratories
- Ganapathy Mohan, Ph.D. Senior Director, Global Analytical Sciences Department, Sanofi-Aventis Pharmaceuticals
- Robert Wherry, Director of Quality Engineering & Technology, Sepracor
- Prentice Curry, Director of Validation, MedImmune
- Richard Denninger, Vice President, Operations, Berlex Laboratories
- Lew Kontnik, Director, Brand Protection/Business Continuity, Amgen
- Karl Hofman, Director, QA Bulk Pharmaceuticals, Bristol-Myers Squibb
- Mark Sander, Senior Director, Manufacturing, Schering-Plough
- Vince Narbut, Vice President, Operations, Biogen, Idec
When: November 1 3
Where: Jacob Javits Convention Center, New York, N.Y.Description: No matter which of the process industries you work in, you'll find profitable solutions for:
- Fluid, Powder and Gas Processing
- Process Efficiency and Productivity
- Lowering Energy and Operating Costs
- Quality Control
- Automation and Integration
- Maintenance
- Regulatory, Safety and Environmental Compliance
- Staff Training and Technical Support
- And much more
Contact: www.chemshow.com
When: November 3-4
Where: Washington, D.C.
Description: You should attend this ASME Continuing Education Short Course if:
- You are an engineer or scientist who is considering using near IR spectroscopy or other process analytical technologies.
- You are a manager in quality control or quality assurance and want to use process analytical technology to save time and money for your department.
- You are in regulatory affairs and must review near IR and other process analytical technology documentation.
- Learn the basic features and benefits of Near IR spectroscopy;
- Review the necessary essential concepts from statistics;
- Learn how to use EXCEL for basic statistical analysis
- Gain a familiarity with chemometrics and the use of chemometric software
- Learn what is required for the use of process analytical technology in a regulated industry
- Overview of near IR and process analytical technology
- Essential concepts from statistics
- Basic concepts of chemometrics
- Real life case studies of process analytical technology
- Use of chemometric software
- Use of near IR instrumentation
- Relevant regulatory guidance.
Contact: ASME International
22 Law Drive
Fairfield, NJ 07007-2900
1-800-THE-ASME (843-2763) or 973-882-1167
E-mail: [email protected]
Website: ww2.asme.org/pd/courseDetail.cfm?CO_ID=1085
When: November 8-9
Where: Ft. Lauderdale, Fla. (call for details)
Description: "Formulating for Nutritional Supplements" is a new two-day introductory course on formulating nutritional supplement tablets and capsules. This course is engineered from the bottom up for new formulators, nutritionists now formulating products and new or small business owners looking for formulating information in a basic, fast course. The graduate will both pass an open-book written examination and successfully construct a nutritional supplement formula before being certified.Contact: Solid Dosage Training Inc.497 Phoenix CircleVallejo, Calif. 94589(925) 352-5724www.soliddosagetraining.comWhat: LogiPharma 2005: Securing Product Authentication and Gaining Global Supply Chain Visibility
When: November 14-17
Where: Ritz Amelia Island Golf and Beach Resort Amelia Island, Fla.Description: LogiPharma 2005 is dedicated entirely to solving your pharmaceutical supply chain and logistics challenges and provides you the greatest number of senior level case studies from global industry leaders. You benefit from innovative case studies that address the most crucial aspects of your day-to-day responsibilities. You get to walk away with valuable strategies on: * Forecasting & Demand Planning; * Global Supply Chain Integration; * S&OP Process Distribution Network Planning; * Inventory Management; * Outsourcing; * Product Authentication; *ePedigree Solutions; * RFIC Implementation; * New Product Introduction; * Channel Management; * Global Logistics & Distribution; * Reverse Logistics; * Electronic Product Code.Contact: To register, call Worldwide Business Research at 1-888-482-6012 or visit https://www.wbresearch.com/secure/logipharmausa/register.html.What: Automation Fair
When: November 16 17
Where: Americas Center, St. Louis, Mo. Description: Manufacturing Perspectives and Automation Fair give you one-on-one exposure to the latest technology, technical sessions, industry experts, hands-on labs, best practices and more. As the largest free educational forum for manufacturing technology, Manufacturing Perspectives and Automation Fair provide the one and only place to hear the latest success stories from manufacturers themselves and engage those that are pushing the manufacturing technology envelope.Contact: www.automationfair.comWhat: CBI's 5th Annual Forum on Generic Drugs
When: November 17-18
Where: Washington, D.C.Description: This year, analysts project that generic drugs will have annual sales in excess of $22 billion. It is also further estimated that the generic drug market will rise from $29 billion to $49 billion in 2007. In the next 10 years, 20 blockbuster drugs, with sales greater than $500 million, are scheduled to lose patent or market exclusivity. This is a constantly growing and evolving industry that continually has market share available for companies to capture.Attend this annual event to gain a comprehensive, objective and balanced look at the important issues impacting todays generics industry and hear insights from industry leaders, regulatory experts and Congressional representatives as well as understand how you can position your company to gain key market share.Contact:Click here to register, or contact the Center for Business Intelligence at 1-800-817-8601, [email protected].DECEMBER 2005What: Pharmaceutical Labeling Summit: Strategies for Long-Term XML and SPL Processes and Future Implications
When: December 5 - 6
Where: Washington, D.C.Description: The move to XML was predicated on a desire to streamline the manner in which data was submitted and examined by the FDA. Utilizing XML and embedding drug and patient data into the labeling will allow automation of other processes, such as e-prescribing, billing and claims. Since XML will be the backbone for many of the functions just mentioned, greater efficiencies can also be had enterprise wide through component based authoring, whereby content designed for one purpose can be easily reused for another and then amended throughout a document or products lifecycle. Thus eliminating the need to re-draft documents for submission. If examined from a strategic perspective, XML has the potential to allow for increased efficiency from R&D on through to regulatory approval and even marketing and packaging.This conference focuses on the long term implementation plans and processes that the mandated SPL guidelines will impose. Attendees learn to implement new technology, improve efficiencies while maintaining federal compliance and evaluate the success of their current transition to SPL.Contact: For more information or to register, please contact the Center for Business Intelligence toll free by phone at 1-800-817-8601 or via e-mail at [email protected].What: IIR's "Technology Transfer for the Pharmaceutical and Biotech Industries" Conference
When: December 5-7
Where: Orlando, Fla.Description: The conference is structured to address five of the biggest hurdles in achieving a successful technology transfer including:
- Project definition and team development
- Compliance
- Validation
- Variations in types of transfers
- Gap analysis.
- Technology Transfer
- Process Engineering
- Process Development
- Drug Product Development
- Analytical Methods
- Process Transfer
- Validation
- Regulatory Compliance Manufacturing
- Research Pharmacists/Senior Scientists
- Technical Affairs Formulation Scientists
- Pharmaceutical and Fine Chemicals Operations
When: December 6-7
Where: LBB's Technical Service Center, Ennigerloh, GermanyDescription: The seminar will provide a sound understanding of the PAT concept and the production processes to which it can be applied. Specific emphasis will be given to NIR technology; presentations will cover established techniques and will explore possibilities and limitations.Speakers will include experienced professionals from both industry and academia. Hands-on demonstrations of practical applications of PAT technologies in use with lab-scale equipment will reinforce seminar presentations.Contact: Reinhard Sievert, L. B. Bohle, 700 Veterans Circle, Suite 100, Warminster, Pa. 18974. Phone: 215-957-1240; fax: 215-957-1237, e-mail: [email protected].What: IQPC's PAT Business Strategies Summit
When: December 6-7
Where: Renaissance Philadelphia Hotel, Philadelphia, Pa.Description: This event explores the economics, financial drivers and organizational challenges behind Process Analytical Technologies (PAT) adoption and implementation.Contact: IQPC. Phone: 800-882-8684 or 973-256-0211; Fax: 973-256-0205; Email: [email protected]; Website: www.iqpc.org/NA-2011-02.What: Advances in Blown Film ConferenceWhen: December 7-8Where: Marriott Biscayne Bay, Miami, Fla.Description: Hosted by Plastics Technology Magazine and Polymer Process Communications, the Advances in Blown Film Conference will provide information on how to manufacture a better film product with increased line speeds at a reduced cost. Topics include extrusion/die/auxiliary equipment/downstream developments, controls/gauging, material advances, printing/surface treatments, plant management, and updates on emerging markets (i.e. medical/pharmaceutical).Contact: To submit an abstract for a technical paper/presentation contact the events Technical Chairman, Jim Callari, publisher of Plastics Technology Magazine, at (646) 827-4848 x7101, or e-mail: [email protected].For additional information about the conference, contact the event coordinator:Melissa LynchPolymer Process Communications44 Cottage PlaceGillette, N.J. 07933Ph: (908) 604-4213E-mail: [email protected]2006What: PITTCON 2006
When: March 12 17
Where: Orlando, Fla.Description: This years theme, Foundations for Science, reflects the Conferences goal to showcase the core tools of analytical chemistry (chromatography, electrochemistry) and spectroscopy (Mass spectrometry, UV-VIS spectroscopy) and to facilitate the convergence of these quantitative techniques with qualitative bioresearch and drug discovery. The committee has selected 26 invited symposia for next years Conference; subjects include Bioterrorism, Bioanalytical Methods, Chromatographic Techniques and Spectroelectrochemical Methods.Contact: www.pittcon.org or call (412) 825-3220.What: INTERPHEX 2006
When: March 21 23
Where: Jacob K. Javits Convention Center, New York, N.Y.
Description: The premier conference and exposition for the field of pharmaceutical manufacturing. The conference features four tracks: manufacturing; sourcing and services; IT; and facilities. The exposition includes more than 1,350 different exhibitors.Contact: www.interphex.com or call Alison Sperling, Conference ManagerPhone: 203-840-5525. Fax: 203-840-9525. E-mail: [email protected].
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