President's Message by Steven Eirschele PE, Lease Crutcher Lewis

www.ispe.org/pacificnorthwest Published by the ISPE Pacific Northwest Chapter Editor: Kimberly Syre Email: ksyre@cox.net Information: Phone 1.949.387.9046 and Fax 1.949.387.9047 NEWSLETTER Issue #2008.3 IN thIS ISSuE President’s Message PAGES 1-2 Vendor Night Photos PAGE 2 November 13 Commuter Conference PAGE 3 ISPE Directory Submissions Due Dec 19 PAGE 4 Genentech Tour Photos & Overview PAGE 5 New Chapter Members PAGE 6 ISPE Washington Conference PAGE 7 Vendor Night Overview and Photos PAGE 8 Golf Tournament Winners and Photos PAGE 9 ISPE’s Industry Acronym List PAGE 10 ISPE Launches New Web Site PAGE 11 2009 Facility of the Year Submissions Due PAGE 12 ISPE Tampa Conference PAGE 13 ISPE Event Calendar PAGE 14 Photo from September’s Vendor Night exhibit show. am excited and proud to be the Northwest Chapter’s new President. With our country just weeks away from electing our nation’s new President, we’re hearing much about ‘change’ from both major candidates. I too have been thinking about change and have a few new ideas for the coming year. Over the past years, our Chapter has tried to reach out to our members here in the NW with events and topics that are relevant and useful to our mostly R&D world. We’ve tried surveys with limited success. My good friend Sue Cost suggested initiating an Advisory Committee. An excellent idea Sue! I envision this to be a group of life science professionals from local NW biotech companies that are interested in supporting our local Chapter and helping us understand what we can do to support them and their companies. Topics might include facility challenges such as design, construction, commissioning and maintenance, LEED/sustainability, energy conservation and training. I’ll be contacting some of our local biotech companies in the near future to discuss this exciting new idea! (continued on next page) I President’s Message by Steven Eirschele PE, Lease Crutcher Lewis President’s Message (continued) Of course, our PNW Chapter 2008 events have been going very well. Our event with our partners at Genentech was well attended and an excellent opportunity to learn, discuss and network! The presentation, entitled “The Creation of Hope,” included a panel discussion and tour of Genentech’s new fill finish facility in Hillsboro, Oregon. This was a no cost event for our members and guests, included heavy hors d’oeuvres and no-host bar and was held at the beautiful Hawthorn Farm Athletic Club. Our special thanks to Gary Schoenhouse and Donna Lake for pulling together a lot of talented professionals that gave us an inspiring introduction, a very informative presentation and well organized tour!! This month is our Vendor Night and Second Annual Golf Tournament events. We will fill you all in on this event in our next newsletter. We’ll continue to focus on building our membership by offering free commuter conferences and other events to both members and guests. We also need to recruit ‘new blood’ into the ranks of our Board. I’m looking forward to the upcoming year as President. CCS Bus Card Ad Steven Eirschele, PE 5/30/08 11:02 AM Page 1 CONTROLLED CONTAMINATION SERVICES, LLC Specializing in: • Biotech • Pharmaceutical • Medical Device • Aerospace • Semiconductor • Training and Consulting • Hi-Performance Green Cleaning Servicing accounts throughout the USA for over 15 years. Call Toll-Free: 1.888.263.9886 www.cleanroomcleaning.com Engineering Architecture Process Technology Process Automation Systems Integration Construction Management Nino Borsoni, PMP - Senior Vice President borsoni@eichleay.com p. 925.363.3112 f. 925.689.7006 Startup & Commissioning Procurement Project Management 2 We invite you to tour as our guests. . . SEATTLE SCIENCE We invite to tour as tour ... . . We invite you you to our guests. FOUNDATION | c o n n e c t i o n c o n t e n t | c o l l a b o r a t i o n STATE OF THE ART FACILITIES SEATTLE SCIENCE FOUNDATION c o n t e n t | c o n n e c t i o n | c o l l a b o r a t i o n STATE OF THE ART FACILITIES STATE OF THE ART FACILITIES an inter national network of innovative physicians & scientists EDUCATION MISSION MEDICAL EDUCATION i n t e r n a t i o n a l nTt w o r k o f i n n oENTER e ECHNOLOGY C v a t i v e an & A foundation for the collaboration between physicians, scientists, technologists, engineers, and educators, fostered in a world class training facility to improve health care through professional education. physicians & scientists EDUCATION MISSION The Seattle Science Foundation (SSF), with access to a world class professional education center, provides a unique opportunity to improve worldwide EDICAL healthcare through education DUCATION and training. The center offers both simulation and cadaveric facilities for surgical and endovascular procedures. State of the art conferencing capabilities with direct links to operating and around the globe. This includes an operating room/endovascular lab & a simulation lab. Includes 8 stations with exceptional lighting and AV conferencing to support interactive training for up to 32 participants. The space is equipped for use with cadaveric specimens as well as anatomical phantom models or simulators. BIO SKILLS LAB M interventional suites enable large and small group interactions Commuter ConferenCe &Seattle SCienCe foundation E TECHNOLOGY CENTER A foundation for the collaboration between physicians, scientists, technologists, engineers, and educators, fostered in a world class training facility to improve health care through professional education. (Renovation to the former Providence hospital) 550 17th Avenue, Suite 600, Seattle, WA 98122 James tower thursday, November 13, 2008 1:00-3:00 pm Seattle Science Foundation’s Mission: Content. Connectivity. Collaboration. The Seattle Science Foundation is a non-profit organization dedicated to the international collaboration among physicians, scientists, technologists, engineers and educators. The Foundation’s training facilities and extensive internet connectivity have been The Seattle Science Foundation (SSF), with access to a designed to foster improvements in health care through professional medical education, training, creative dialogue and innovation. world class professional education center, provides a unique Please join your ISPE The center offers both simulation and cadavericfor a tour of the Seattle Science Foundation, lead by Scientific Director, Dr. and training. Pacific Northwest Chapter Robert Franza facilities for surgical and endovascularCollins. State of the will share with you the ideas behind this creative, pioneering and expressive and Architect, Arlan procedures. They resource for our conferencing capabilities with direct linkseducational communities. art scientific, medical and to operating and interventional suites enable large and small group interactions around the globe. opportunity to improve worldwide healthcare through education Schedule 1:00 pm - 1:15 pm 1:15 pm - 3:00 pm 3:00 pm Registration Introduction & Tour with Bob Franza & Arlan Collins Q&A and Social in Foundation’s Library/LoungeBeverages and appetizers provided. Program is free to ISPE Members Non-Members $25.00 Please register with Katie at aminc2@comcast.net Click here for directions: http://www.seattlesciencefoundation.org http://www.bomasouthpugetsound.org/flash/ispe/SSF-Map.pdf PHARMACEUTICAL DOES YOUR COMPANY OFFER SERVICES OR OR BIOTECH INDUSTRY SUPPLIES TO THE ON THE WEST COAST? 2009 ISPE WEST COAST RESOURCE DIRECTORY ALL ADS ARE 4-COLOR! sponsored by the following ISPE Chapters GREATER LOS ANGELES PACIFIC NORTHWEST SAN DIEGO AND SAN FRANCISCO/BAY AREA The ISPE West Coast Resource Directory is an invaluable way for companies to inexpensively reach the decision makers and connect with those purchasing products and services. • Book version is mailed to nearly 2800 ISPE members on the West Coast. • CDs are available at Chapters events. • The electronic version is posted on all four ISPE Chapter Web sites: www.ispe.org/greaterla www.ispe.org/sandiego www.ispe.org/sanfrancisco www.ispe.org/pacificnorthwest Available in Book, CD and Electronic Versions: Reserve Your Ad Today by Visiting: http://event-confirmation.com/ispela_meetings.htm QUESTIONS? CALL 949/387-9046 FROM SAN FRANCISCO CALL ne for Deadli Artwork nt & Payme r 19 888/275-0189 be Decem 8 200 FROM SAN DIEGO CALL 800/869-9621 4 Project HOPE: Hillsboro Oregon Pharmaceutical Expansion by Clint Pepper, PhD of HemCon Medical Technologies, Inc. he new Genentech fill finish facility in Hillsboro has generated a lot of excitement here in the Northwest. Genentech is in the final stages of construction and they generously offered to let us take a peek inside. The tour was well organized, informative and strongly emphasized safety. The individuals at Hoffman Construction were professional and of great help in safely guiding us though the construction zones. The tour included a walk through of the utility area, materials management, buffer prep, filling and packaging as well as the future work spaces and community lunch area. The new commercial scale lyophilizers were particularly interesting and the isolator for one of the filling machines was in mid installation. Later that evening we had a chance to get together again to see the Genentech presentation: “The Creation of HOPE. An overview to the drivers and process of developing an efficient Fill Finish Facility”. Gary Schoenhouse, the Hillsboro Fill Finish - Core Team Leader, began the proceedings with introductions and an overview of what the audience would see. Barry Starkman, the Hillsboro Plant Manger, first gave a detailed account of the drivers that led Genentech to select this site. He then inspired everyone as he described how the Genentech philosophy centered on helping patients was such a great motivator for him and his team. Then Andrew Cunningham, from the Architectural and Engineering firm Flad and Associates, provided an excellent presentation on the nuts and bolts of the design and construction. Emphasis was placed on the strategies used during design reviews to ensure they were effective, the implementation of extraneous cost avoidance strategies, and the evaluation of the design and construction metrics against industry bench marks. Following the presentation other individuals such as Carl Albertson of BioKinetics, Darin McKenzie of Hoffman and Nathan Moroney of Hoffman joined the others for a discussion panel which fielded more than dozen great questions from the audience. After the event several attendees were very complimentary about the quality of the tour and presentation. The Northwest Chapter of ISPE would like to whole heartedly thank Genentech and everyone else who helped out for their complete support and generosity. T 5 Simon E.J. Forder Principal Consultant and CEO 400 Oyster Point Blvd, Suite 520 South San Francisco, CA 94080 650.588.2660 office 650.588.2857 fax 415.748.8753 cell simon.forder@hyde-ec.com www.hyde-ec.com WELCOME NEW ChAPtER MEMBERS Mid June - September 2008 Nicholas Bolland, Faithful + Gould Kenneth Dodge, PuRODI Systems Carol Dyck, Neova technologies Matthew Callahan, Cascade Integration & Dev Patrick Endicott, hollister Stier Laboratories Greg Johnston Sr., hoffman Construction Company Camelia Kouki, Walden university Gregory Larsen, MKS Jean Feagin, university of Washington Darin MacKenzie, hoffman Construction Company Joseph Sango, Saint-Gobain Performance Plastics Debbie Schlosser, Medtronic Physio Control Dana Settell, Bend Research, Inc. (BRPPD) Christopher thomas, CMC ICOS Biologics Janise Watson, Gilead Sciences, Inc Erik Westover, Sellen Construction M. Michele Sainte-Starbuck, CollinsWoerman VALIDATION COMMISSIONING Jason Robertson TRAINING AUDITS jason.robertson@crbusa.com Jeff Rozelle jeff.rozelle@crbusa.com 500 Airport Blvd, Suite 100 • Burlingame, CA 94010 Toll-Free (888) 242-0559 • Office (650) 320-1788 • Fax (650) 320-1789 Phone: 816-880-9800 Fax: 816-880-9898 www.crbusa.com www.crbbuilders.com CONSULTING  DESIGN  CONSTRUCTION  COMMISSIONING  QUALIFICATION www.propharmagroup.com High Purity Liquid Handling Products for Pharmaceutical & Biotech Industries 1-800-726-4835 Sandra Medlin Bob Miller Technical Sales Representative (510) 290-1232 Cell smedlin@sani-techwest.com bmiller@sani-techwest.com Technical Sales Representative (510) 967-9397 Cell 321 Irving Dr., Oxnard, CA 93030 www.sani-techwest.com 6 “We couldn’t be more excited about the significant contributions we are getting this year from experts representing the world’s regulatory agencies,” said Doug Ellsworth, ISPE’s International Regulatory Affairs Advisor. ”This will truly be an opportunity for pharmaceutical professionals to learn firsthand about emerging global industry trends and practices.” In addition to the wide variety of presenters from top pharmaceutical companies such as Abbott, AstraZeneca, BristolMyers Squibb, Johnson & Johnson, Schering Plough, Vetter, and Wyeth, attendees will have the opportunity to interact with representatives of international regulatory agencies during the following discussions: • Janet Woodcock, Director of the Center for Drug Evaluation and Research at the US FDA will be delivering a keynote address. • Product Quality Lifecycle Implementation (PQLI) and a practical approach to global implementation of ICH documents. Regulators confirmed for this session:, Yukio Hiyama (NIHS), Frank Holcombe (US FDA), Jacques Morenas (AFSSA PS, France), Moheb Nasr (US FDA), Jean-Louis Robert (EMEA), and Joe Famulare (US FDA). I International All-star Speaker Line-up at Annual ISPE Event • Risk-MaPP and use of risk-based techniques to manage cross contamination. Regulators confirmed for this session: Tor Graberg (PIC/S). • Financial, legal, technical, and regulatory issues facing biosimilars. Regulator confirmed for this session: Dr. Anthony Ridgway (Health Canada). • Quality Laboratory Facilities Baseline® Guide: A Roadmap to a Compliant, Cost-effective Lab. Regulator confirmed for this session: Fred Fricke (US FDA). • Competing in the Global Marketplace. Regulator confirmed for this session: Ali Afnan (US FDA). • hot topics in Process Validation. Regulator confirmed for this session: Rick Friedman (US FDA). Education sessions at the 2008 ISPE Annual Meeting will follow seven tracks of interest: Regulatory, Innovation, Manufacturing Operations, Engineering Design, Investigational Products, Project Management, and Efficient and Effective Compliance. Networking activities, exhibits, and special events will also allow for one-on-one time with colleagues for further knowledge and best practice sharing. SPE has a full line-up of regulatory speakers presenting at the 2008 ISPE Annual Meeting being held 26-29 October in Boca Raton, Florida, USA. www.ISPE.org/washington Engineering Regulatory Compliance Perspectives straight from regulatory officials on regulatory hot topics, trends, and observations, as well as interactive sessions on Product Quality Lifecycle Implementation (PQLI). ISPE Washington Conference 1-4 June 2009 Sponsorship and Table Top Exhibit Opportunities Available JW Marriott Pennsylvania Avenue Washington, D.C., USA 7 ellevue in mid-September was once again the venue for our Chapter’s annual Vendor Night. The evening was informative and enjoyable. An intimate but enthusiastic group of Chapter Members enjoyed the exhibits, the social hour and the educational presentations. An initial product-services perusal and social hour was punctuated with a brief business overview by new President, Steve Eirschele. Two presentations, additional visiting time, announcements and a raffle rounded out the activities. Chuck McBride, the first speaker, is the business Development Manager for ProsCon Americas Region. The company designs, builds and installs Modular BioPharma Facilities, Modular Solvent Recovery Systems and Modular Process Skids. Chuck’s presentation, Mitigating Risks on Fast Track Projects Using Modular Construction, was most interesting and followed by discussion on the practical application of modular construction for our largely bio-tech and institutional northwest clientele. B Vendor Night Overview by M. Michele Sainte-Starbuck AIA, CollinsWoerman Mark Thaler, with the ISPE Delaware Valley Chapter, gave an educational talk on the New ASTM-E2500 Validation Standard viewpoint and approach. This new consensus standard is science- and risk-based. Mark’s presentation and subsequent audience dialogue included details of the standard and how to apply them. The good news is that the cost and effort to achieve validation can now be reduced, without compromising quality of equipment and systems operations. Closing activity was highlighted with generous raffle gifts to lucky ticket holders. The Chapter gives a big thank you and round of applause to participating vendors: Allegheny Bradford Corporation Arc Machines, Inc. Commissioning Agents, Inc. CRB Engineers-Builders Engineered Products and Services Evergreen Engineering Fluor Enterprises, Inc. Harder Mechanical Contractors, inc. InVitria Kinetics Mar Cor Meacon Corporation Millipore Corporation MKS Instruments NNE Pharmaplan Paul Mueller Company PCE Pacific/Emerson Process Management Pharmeng USA, Inc. Powers of Automation Ryan Herco Flow Solutions Sani-Tech West Sharp Mixers Steriflow Valve Steris Corporation 8 Golf Tournament Photos by Steven Eirschele, Lease Crutcher Lewis C ongratulations to this year’s Golf Tournament winners: • Longest Drive: Tim Grimes • Closest to the Pin: Chris Sterzinger • 1st Place Intermediate Foursome: Jeff Rozelle, Ben Mitchell, Jaime Young & John Rubero • 2nd Place Intermediate Foursome: Paul Koshiyama, Steve Cruft, Mark Haldeman & Jim Proulx and you’ll be rewarded! Give the Gift of Membership ISPE membership offers benefits for professionals at every stage in their career. www.ISPE.org/givethegift 9 ISPE’s New Web Site Features Industry Acronyms he “Applied Terminology for the Biopharmaceutical Industry” is the result of many years of gathering material from sources such as scientific journals, industrial magazines, professional organizations, the World Wide Web, industry seminars, company guides, vendor and manufacturer information, national and international codes, and diverse individuals. This compilation of definitions, abbreviations and acronyms relating to the relatively new Biotechnology industry, as well as the more established Pharmaceutical industry, is intended to be a handy reference for owners/users, engineers, designers, technicians, service providers, and other individuals involved in this dynamic industry. It includes terms used in water and steam systems, drug processing, medical devices, biology, chemistry, computer technology, regulatory affairs, HVAC, etc. It is the author’s hope that this reference document will help, either introduce or broaden the understanding of the industry and all its subtleties. About the Author/Editor Ms. Michelle M. González, Senior Principal Corporate Engineer – Director (Retired), Amgen Inc., Thousand Oaks Ms. Gonzalez has more than 25 years experience in the pharmaceutical, and biotech industries. Throughout her engineering career, she has had extensive experience in leadership activities dealing with facilities and process systems design, facilities engineering, and management of projects. Since relocating to the United States in 1965, she has held technical positions of increasing responsibility in mechanical and process engineering with firms such as Shell Oil, Kaiser Engineers, Bechtel Corporation, Fluor Daniel, and Amgen. Ms. Gonzalez holds an MS in Architecture from the Pontificia Universidad Javeriana in Bogotá, Colombia. She has been a regular lecturer at the Stanford School of Engineering, and holds professional memberships in the American Institute of Chemical Engineers (AIChE), and the American Society of Mechanical Engineers (ASME) Bioprocessing Equipment (BPE) Standard, where she serves as Chair of the BPE’s T Subcommittee on Surface Finishes, voting member of the Executive and Main Committees, as well as the Certification, and Dimensions & Tolerances Subcommittees. She is also a member of the Interphex Conference Advisory Board. As an active member of the International Society for Pharmaceutical Engineering (ISPE) since 1989, she has been a regular speaker, a member of the Membership Committee (MSC), the North America Educational Committee (NAEC), and the Body of Knowledge Committee (BOKC); President of the Greater Los Angeles Chapter (2007-2008), and a participating member in the preparation of the ISPE Good Practice Guide for Commissioning and Qualification of Pharmaceutical Water and Steam Systems, the Biopharmaceutical Manufacturing Facilities Baseline® Guide, the Packaging, Labeling and Warehousing Operations Baseline® Guide, the Laboratories Baseline® Guide, and the revision of the Water & Steam Baseline® Guide. She is also the author and editor of ISPE’s Glossary of Applied Terminology for the Pharmaceutical Industry. Ms. González has authored various technical papers dealing with materials of construction for the biopharmaceutical industry, “single use” products technology, facilities programming, pilot plants, and biotechnology process systems. how Do You Access the Glossary Whether the interested party is an ISPE member or not, the Glossary can be readily reached by typing http://www.ispe.org/ and on the left hand column Products and Services, click on the + sign for Resource Center; click on the sub-field Glossary and the section titled Glossary of Applied Terminology for the Pharmaceutical Industry will open (http://www2.ispe.org/ glossary2/). Three main fields will appear below the Section title, About the Glossary (general description, sources of the terms defined, and information about the author/editor), Find Definition by Term and/or Language, and Browse All Terms (5742 definitions of terms and/or acronyms in the English language). A Foster Wheeler Company Susanne Lage’ Cost Vice President, Business Development • Process Development Emeryville, CA & Scale-Up Direct: 1.510.594.3003 • Critical Utility Design sue.cost@biokinc.com • cGMP Upgrades www.biokinc.com • cGMP Facility Design • Debottlenecking • Custom Process Equipment • Commissioning/Qualification/Validation 10 ISPE Launches New Site To Better Meet Industry Needs I SPE has launched its new Web site (www.ISPE.org) after extensive usability studies and feedback from its Members. “Our Members told us that there were some things we could do to make their Web site experience easier and more effective while providing the information they need to be successful in their work,” said ISPE President and CEO Robert Best. “We listened and used their feedback to carefully re-design the Web site to serve our membership better.” The new www.ISPE.org design and functionality includes: • Cleaner, easier-to-read pages • More purpose-driven and intuitive navigation • Easier access to industry and regulatory news and information • Robust functionality that enables networking and community-driven communication • New content intended to address the challenges of today’s pharmaceutical professionals In tandem with the launch of the new Web site — and in effort to address the industry’s need for current, relevant, and useful content — is the release of ISPE’s new Knowledge Brief publications and a downloadable version of ISPE’s acclaimed Glossary of Applied Terminology. Additional features and Web site functionality will be available in the coming months. Knowledge Briefs are concise, easy-to-read resources that help industry professionals get up-to-speed quickly on a wide variety of disciplines and topics. The first three Knowledge Briefs are: • Biotechnology Basics (Level – Basic) This Knowledge Brief provides basic concepts explaining the science of biotechnology and how science and process are combined to lead to the manufacture of a human therapeutic product. • Commissioning and Qualification of Biopharmaceutical Facilities (Level – Intermediate) This Knowledge Brief summarizes the considerations involved in the commissioning and qualification of a biopharmaceutical manufacturing facility. • Quality by Design (Level – Intermediate) This Knowledge Brief provides and explains the basic elements of Quality by Design (QbD). Knowledge Briefs are free to ISPE Members and can be downloaded by visiting www.ISPE.org/knowledgebriefs. Nonmembers will pay $5US (€3) for each Knowledge Brief. In addition to the release of the first three Knowledge Briefs, ISPE plans to release its first downloadable version of the comprehensive Glossary of Applied Terminology in the fall of 2008. The glossary is designed to help industry professionals with daily job functions, understand terminology used in ISPE’s technical documents and education seminars, and standardize industry terms around the globe. The glossary, which will be in PDF format and free to ISPE Members, contains more than 5,800 terms and includes abbreviations, acronyms, and terms focusing on specific areas in biotechnology and pharmaceutical science and manufacturing such as computer technology, manufacturing processes, water treatment, welding, metallurgy, HVAC, medicine, biology, chemistry and many other subjects. For more information on these or other ISPE technical documents and publications, visit www.ISPE.org/publications. http://www.ispe.org/cs/2008_san_diego_training/2008_san_diego_training 11 I Innovative Facilities Invited to Submit for The concept of Verification 2009 Facility of the Year Awards is holistic and is defined as “a systemic appr President’s Message ( SPE, together with INTERPHEX and Pharmaceutical Processing magazine announced a call for global pharmaceutical manufacturing organizations to submit details of newly constructed or renovated facilities for the 2009 Facility of the Year Awards (FOYA) program. FOYA, now in its fifth year, has quickly become the pre-eminent program that recognizes and disseminates best practices in the pharmaceutical manufacturing industry. It awards those companies that utilize new and innovative technologies to reduce the cost of production of high quality medicines and enhance capital project delivery. This global program attracts submissions from more than 20 countries from around the world. Past winners have come from Belgium, Canada, China, Denmark, Germany, Ireland, Japan, the United Kingdom, and the United States. “Receiving recognition as a Facility of the Year Award winner generates unsurpassed opportunities for manufacturers and their key supporting organizations to showcase their ingenuity,” said Clive Mullins, Chairman of the Facility of the Year Awards Committee. “This program really motivates professionals in the pharmaceutical industry to share best practices within the global community.” gly or in combination, are fit for intended use, have been properly install The FOYA program OQ /instituted to recognize the accom- to be eliminat mean that the IQ / was PQ approach is wrong or is going plishments, commitment and dedication of individuals in comvalidation is done. We are trying to arrange a speaker on this topic for l panies worldwide and to share their innovative and advanced notice for an upcoming meeting. pharmaceutical manufacturing technology for the benefit of their peers and all global consumers. The judging panel will selectrest of the programming for the Year Award fromtour at the UW Med The the winner of the Facility of this year includes a among Category Winners thatPortland, and excellence in: year member’s activity muter conference in demonstrate our end of the Please Innovation • events. Process be on the lookout for e-mail notices for these events and be interested. Execution • Project • Equipment Innovation • Soon we will be electing a new slate of Chapter Officers and Board Mem Facility Integration • Sustainability more participation at this level of the Chapter. The commitment is to att • Operational Excellence the program events for the year. Some of the meetings are teleconferen schedule is minimized. Please consider taking on a in Once the Category Winners are selected by the judgesmore active volunte early have any questions, comments, suggestions,during wish to volunte you 2009, they will be recognized and introduced or you INTERPHEX2009 in New York City, New York, USA. The and my cell number is (484) 680-3789. announcement of the winner of the 2009 Facility of the Year Award will take place at ISPE’s Annual Meeting in November 2009 in San Diego, California, USA. Pharmaceutical Paul Lamm Engineering and Pharmaceutical Processing magazines will provide extensive coverage of the winners. Submission deadline is December 1st. For complete information about the awards program and submission procedures, please visit www.facilityoftheyear.org or contact Marni Schribman, ISPE Communications Manager, by tel: +1-813960-2105 or by email: mschribman@ispe.org. CCS Bus Card Ad 5/30/08 11:02 AM Page 1 CONTROLLED CONTAMINATION SERVICES, LLC Specializing in: Biotech Pharmaceutical Medical Device Aerospace Semiconductor Training and Consulting Hi-Performance Green Cleaning Servicing accounts throughout the USA for over 15 years. Call Toll-Free: 1.888.263.9886 www.cleanroomcleaning.com No Standard Is Too High For ABC. ALLEGHENY BRADFORD CORPORATION jas Regional Manager - Dori Carlson Skids • Tanks • Valves • Pumps Heat Exchangers • Filter Housings 1522 South Ave., Lewis Run, PA 16738 800-542-0650 • www.alleghenybradford.com 12 2 CONSU www.ISPE.org/tampa Implementing Development and Manufacturing Technology ISPE Tampa Conference 2-5 March 2009 Grand Hyatt Tampa Bay Tampa, Florida, USA Sponsorship and Table Top Exhibit Opportunities Available For Contamination and Corrosion Headache Relief AS T RO PAKE NO L active ingredients Contact Us Northwest Fluid Solutions 11814 NE 116th Street (425) 821-4515 Kirkland, WA 98034 sales@nw-fluid.com (425) 650-8511 Fax Locally Owned and Operated Bioprocess Fluid Components & Solutions 13 2008/2009 Board of Directors Officers President Steven Eirschele, Lease Crutcher Lewis Vice President Christopher Procyshyn, VanRx Pharmaceuticals treasurer/Newsletter Chair David Spanel, Amgen, Inc. Secretary Clint Pepper, Ph.D. HemCon Medical Technologies, Inc. Director M. Michele Sainte-Starbuck, Collins Woerman Past President/Student Affairs Chair Paul Lammers, AMEC E&C Services, Inc. Chapter Managers: Lianna Collinge Katie Bohocky Association Management Inc. P.O. Box 6906, Tacoma, WA 98417 Tel: 877-460-5880 Fax: 253-265-3043 aminc2@comcast.net For advertising deadlines/costs: www.ispe.org/pacificnorthwest For additional ISPE Educational Offerings and Publications ISPE 2008 Event Calendar 26-29 October ISPE Annual Meeting tracks on: • Innovation • Regulatory/PQLI/PAt • Investigational Products • Manufacturing Operations • Project Management • Engineering Design • Efficient and Effective • Compliance Boca Raton, FL www.ispe.org ISPE San Diego training Lower Production Costs, Improve Process Efficiency, Increase Production Quality, and Meet Regulatory Requirements www.ispe.org Annual holiday Social 17-20 November 4 December ISPE 2009 Event Calendar 2-5 March 17-19 March 1-4 June 8-11 November ISPE tampa Conference INtERPhEX 2009 ISPE Washington Conference ISPE Annual Meeting San Diego, CA www.ispe.org ISPE is a global, not-for-profit membership organization that provides education, training, and technical publications to pharmaceutical manufacturing professionals. All events subject to change due to availability of venue and speakers. For more details please visit ISPE Pacific Northwest Web site www.ispe.org/pacificnorthwest and ISPE’s Global Calendar www.ispe.org 14