22-25 February • Grand Hyatt Tampa Bay • Tampa, Florida, USA ISPE Tampa Conference Applying Solutions to Emerging Industry Challenges 10 Exhibitor Directory www.ISPE.org/2010TampaConference AdvanceTEC, L.L.C. Table #39 11300 Business Center Dr. Richmond, Virginia 23236 USA Tel: +1-804-378-1550 Fax: +1-804-378-4055 www.advancetecllc.com Contact: Bryan Phelan bryanp@advancetecllc.com AdvanceTEC is a cleanroom design/ build general contractor with expertise in the integration of modular cGMP finishes and systems. Our services ranges from cGMP architectural envelopes to full turnkey projects, including process utilities integration. Please call AdvanceTEC to see how we can help you on your next project: 1-877-560-8881. AES Clean Technology, Inc. Table #32 422 Stump Rd. Montgomeryville, Pennsylvania 18936 USA Tel: +1-215-393-6810 Fax: +1-215-393-6819 www.aesclean.com Designs, builds and manufactures cGMP clean rooms. Manufacturer and distributor of the modular AES Pharma Wall and Walk-On Ceiling System. Allegheny Bradford Group of Companies Give-Away Sponsor Table #54 11 Lincoln Dr. Lewis Run, Pennsylvania 16738 USA Tel: +1-800-542-0650 Fax: +1-814-362-2574 www.abccorporate.com Contact: Chuck Ridenour cridenour@alleghenybradford.com Experts in process equipment, process equipment solutions and specialty services. Expanded products and service capabilities with over 40 years of processing experience. Analytics Corporation Astro Pak, Corp. Table #40 270 E. Baker St., Suite 100 Costa Mesa, California 92626 USA Tel: +1-562-293-3516 Fax: +1-562-293-3557 www.astropak.com Global leader of passivation, high purity cleaning, and derouging technology for stainless steel systems and components. Bausch + Stroebel Machine Company, Inc. Table #24 21 Commerce Dr. North Branford, Connecticut 06471 USA Tel: +1-203-484-9933 Fax: +1-203-484-9939 www.bausch-stroebel.com Contact: Miron Mironov Miron.Mironov@bausch-stroebel.com Machines to wash, sterilize/depyrogenate, fill, close, check, convey and label containers like ampoules, cartridges, disposable syringes, vials and bottles of all kinds. Belimed, Inc. Table #63 2284 Clements Ferry Rd. Charleston, South Carolina 29492 USA Tel: +1-843-216-7424 Fax: +1-843-216-7707 www.belimed.us Contact: Gordon Leichter gordon.leichter@belimed.us Design, engineer and manufacture high quality, innovative sterilization and washing systems for the pharmaceutical, biotech, research and laboratories. BIOCORP Table #53 212 Carnegie Center, Suite 206 Princeton, New Jersey 08540 USA Tel: +1-609-524-2561 Fax: +1-609-520-8731 www.biocorp.fr Innovation for capping sterile drug products: LYOSEALs allow capping in class A, in the freeze dryer for lyophilized products. Table #21 10329 Stonyrun Ln. Ashland, Virginia 23005 USA Tel: +1-804-365-3000 Fax: +1-804-365-3002 www.analyticscorp.com 2 Tampa Conference 2010 www.ISPE.org BioPharma Systems Table #74 1365 Landis Dr. North Wales, Pennsylvania 19454 USA Tel: +1-888-554-5885 Fax: +1-919-573-9490 www.b-psystems.com Contact: David Pallister dpallister@b-psystems.com Contact: Mark Walkush mwalkush@b-psystems.com BioPharma Systems represent the following principals: Telstar Life Science Solutions. PalPharma Inc. Materials Handling PBSC. Clean Components and Decontamination. FP Developments. Vial inspection and transfer. BioTeknica Table #26 250 Bird Rd., Suite 216 Coral Gables, Florida 33146 USA Tel: +1-305-445-2080 Fax: +1-305-445-2515 www.bioteknica.com Bosch Packaging Technology Table #27 8700 Wyoming Ave. N. Minneapolis, Minnesota 55445 USA Tel: +1-763-424-4700 Fax: +1-763-493-6776 www.boschpharma-na.com Contact: Jeff Jackson sales@boschpackaging.com Bosch Packaging is the world leader in the design and manufacture of pharmaceutical processing and packaging equipment. Capmatic Table #31 12180 Albert-Hudon Montreal H1G 3K7 Canada Tel: +1-514-322-0062 Fax: +1-514-322-0063 www.capmatic.com ChargePoint Technology Table #36 211 Potters Dr. Bayville, New Jersey 08721 USA Tel: +1-732-269-0606 Fax: +1-732-269-0406 www.thechargepoint.com Contact: Darren Garvey darren.garvey@thechargepoint.com ChargePoint Technology supply containment valves, docking systems and material handling solutions for the safe transfer of solid and semi-solid products through www.ISPE.org Tampa Conference 2010 a complete range of pharmaceutical, biotechnical, chemical and food & beverage manufacturing processes. Chase-Logeman Corporation Table #43 303 Friendship Dr. Greensboro, North Carolina 24709 USA Tel: +1-336-665-0754 Fax: +1-336-665-0723 www.chaselogeman.com cGMP Liquid Filling Equipment & Systems. Compact monoblock designs with built-in taregross check weighing, filling line integration, and barrier isolator filling systems. Cleanseal Doors - An ASI Technologies Company Table #23 5848 N. 95th Ct. Milwaukee, Wisconsin 53225 USA Tel: +1-414-698-5478 Fax: +1-414-464-9863 http://www.cleansealdoors.com High performance and custom door systems. Cleanseal door systems meet cGMP, EMEA, FDA and clean room requirements to Class 1. COMECER Give-Away Sponsor Table #71 429 Lenox Ave. Miami Beach, Florida 33139 USA Tel: +1-305-573-6020 Fax: +1-305-847-0837 www.COMECER.com/isolation Contact: Loris Rinaldi lrinaldi@comecer.com Providing customized turn-key solutions for containment and aspetic applications from R&D to commercial scale filling lines. Commissioning Agents, Inc. Host Sponsor Table #6 P.O. Box 34320 Indianapolis, Illinois 46234 USA Tel: +1-317-271-6082 Fax: +1-317-271-6097 www.commissioningagents.com Contact: Tim Howard tim.howard@cagents.com Premier provider of commissioning and qualification services, including factory inspections, construction QA oversight, start-up, automation, cleaning, and regulatory compliance. 3 EDI Table #70 780 Carillon Pkwy, Suite 100 St. Petersburg, Florida 33716 USA Tel: +1-727-299-9304 Fax: +1-727-299-9355 www.edatai.com Contact: Jim Lindsay jlindsay@edatai.com Full service consulting firm established in 1999 to fulfill the ever-growing needs of the Maximo user. Emerson Table #37 12301 Research Blvd., Suite 3 Austin, Texas 78759 USA Tel: +1-512-751-9251 Fax: +1-512-751-9251 www.emersonprocess.com Manufacturing automation with expertise, products, and solutions related to measurement, control, batch automation, and operations managements. EnGuard Systems Table #11 5460 Victory Dr., Suite 300 Indianapolis, Indiana 46203 USA Tel: +1-317-443-3723 Fax: +1-317-253-4592 www.enguardsystems.com EnGuard Systems designs and manufactures barrier/isolators provide totally contained processing of potent compounds, solid dosage, and parenteral products. Flow Sciences, Inc. Table #34 2025 Mercantile Dr. Leland, North Carolina 28451 USA Tel: +1-910-763-1717 Fax: +1-910-763-1220 www.flowsciences.com Contact: Peter Burke pburke@flowsciences.com Flow Sciences’ mission is to provide containment systems for laboratory, pilot plant and manufacturing areas. The products are designed to protect operators from exposure to hazardous particulates and vapors while performing delicate operations. Foster Wheeler Table #35 Shinfield Park Reading, Berkshire RG2 9FW United Kingdom Tel: +44-1-189-131234 Fax: +44-1-189-132028 4 www.fwc.com International engineering and construction contractor, providing a full range of services for the pharmaceutical industry. Getinge USA, Inc Table #61 1777 East Henrietta Rd. Rochester, New York 14623 USA Tel: +1-585-272-5165 Fax: +1-585-272-5372 www.getingeusa.com Contact: Hayley Yahn Hayley.Yahn@Getingeusa.com Getinge Group, Getinge USA, Inc is a medical device manufacturer/distributor that provides complete solutions for effective and efficient cleaning, disinfection and sterilization in the healthcare and life science sectors. General Econopak, Inc. Table #50 1725 North 6th St. Philadelphia, Pennsylvania 19122 USA Tel: +1-215-763-8200 Fax: +1-215-763-8118 www.generaleconopak.com GenesisSolutions Table #76 100 Danbury Rd, Suite 105 Ridgefield, Connecticut 06877 USA Tel: +1-203-431-0281 Fax: +1-203-431-3643 www.genesissolutions.com Contact: Mike Greenholtz mgreenholtz@genesissolutions.com GenesisSolutions has a proven track record of implementing Best in Class life cycle maintenance practices. Over the past decade our Reliability Program has been deployed globally across multiple industry verticals. groninger USA, LLC Table #55 2520 Whitehall Park Dr., Suite 800 Charlotte, North Carolina 28273 USA Tel: +1-704-295-9000 Fax: +1-704-295-9020 www.groningerusa.com Contact: Joerg Bengelsdorf j.bengelsdorf@groningerusa.com groninger USA manufactures fill/finish processing lines for the pharmaceutical and cosmetic industries. Our core competencies are customized, turnkey aseptic liquid fill/ finish lines. Tampa Conference 2010 www.ISPE.org HECHT Technologie GmbH Table #25 Schirmbeckstraße 17 Pfaffenhofen/Ilm 85276 Germany Tel: +49 8441 89560 Fax: +49 8441 895656 www.hecht.eu Contact: Richard Denk r.denk@hecht.eu Our customized solutions include Flexible containment, pneumatic powder conveying systems, and high precision metering units. Honeywell International Table #59 3079 Premiere Pkwy Duluth, Georgia 30097 USA Tel: +1-843-903-0850 Fax: +1-843-903-0871 http://hpsweb.honeywell.com Contact: Jerry Rose jerry.rose-1@honeywell.com Honeywell helps reduce risk by delivering projects on time, helping you achieve and maintain regulatory compliance, and protecting your investment with our support services. Hyde Engineering + Consulting Table #57 6260 Lookout Rd., Suite 520 Boulder, CO 80301 USA Tel: +1-303-530-4526 Fax: +1-303-581-0839 www.hyde-ec.com Contact: Todd McLaren todd.mclaren@hyde-ec.com Hyde Engineering + Consulting has over 15 years experience providing high value engineering, planning and compliance solutions to the biopharmaceutical, pharmaceutical and clean technology industries. IMA Edwards Table #1 2175 Military Rd. Tonawanda, New York 14150 USA Tel: +1-716-695-6354 Fax: +1-716-695-6367 www.imaedwards.com Contact: Ernesto Renzi ernesto.renzi@imaedwards.com A leading supplier of parenteral packaging lines including filling, inspection, freeze-drying and automated vial handling systems. JOA North America Table #14 7422 Carmel Executive Park, Suite 201 Charlotte, North Carolina 28226 USA Tel: +1-704-341-9392 www.ISPE.org Tampa Conference 2010 Fax: +1-704-341-9325 www.joa-nam.com Contact: Eric Virkler eric.virkler@joa-nam.com JOA specializes in designing and optimizing dust control and collection systems for powder handling processes. We apply our own fluid modeling software and patented hardware for guaranteed containment results. L.J. Star Incorporated Table #52 PO Box 1116 Twinsburg, Ohio 44087 USA Tel: +1-330-405-3040 Fax: +1-330-405-3070 www.ljstar.com Contact: Daniel Schreck view@ljstar.com L.J. Star Incorporated provides an extensive line of process observation equipment sight glasses, non-ex lights, sanitary fittings, and level gage instrumentation. Product lines include Metaglas® Safety Sight Windows, Lumiglas® Explosion Proof Lights and Cameras, Visual Flow Indicators, Sight Ports, Sanitary Clamps, Magnetic Level Gages and Gage Glass. Marchesini Packaging Machinery, Inc. Give-Away Sponsor Table #38 43 Fairfield Place West Caldwell, New Jersey 07006 USA Tel: 1+973-575-7445 Fax: 1+973-575-4051 www.marchesiniusa.com Contact: Roger Toll roger.toll@marchesiniusa.com Sales and service for full range of packaging equipment. MECO Table #15 501 Community Dr. Fuquay-Varina, North Carolina 27526 USA Tel: +1-919-557-7330 Fax: +1-919-557-7331 www.mecobiopharm.com Contact: Don Batot dbatot@meco.com MECO will have catalogs and pictures displaying its vapor compression stills, WFI stills, pure steam generators and feed water pretreatment systems. 5 METALL + PLASTIC Table #22 1222 W Golf Rd. Libertyville, Ilinois 60048 USA Tel: +1-847-219-5443 Fax: +1-847-247-1113 www.metall-plastic.de Contact: Jim Vogel j.vogel@metall-plastic.de METALL + PLASTIC is a world leading manufacturer of isolation technology and ebeam decontamination technology. MIT Professional Education 77 Massachusetts Ave. Bldg 35-433 Cambridge, Massachusetts 02139 USA Tel: +1-617-324-1902 Fax: +1-617-258-8831 http://professionaleducation.mit.edu Contact: Tavish Baker tavish@mit.edu MIT Professional Education provides science and engineering professionals a range of programs that offer full or part time academic study, skills for career reentry or retooling, and more than fifty 2-5 day intensive courses - all taught by faculty from across the Institute. In addition, MIT Professional Education offers customized programs for a diverse set of corporate clients. Mundy PharmaTech Table #45 11150 South Wilcrest Houston, Texas 77099 USA Tel: +1-281-530-8711 Fax: +1-281-530-8561 www.MundyPharmatech.com We offer cost and productivity improvement consulting and are a contract workforce provider with demonstrated expertise. ORTEC Table #46 Six Concourse Pkwy, Suite 1930 Atlanta, Georgia 30328 USA Tel: +1-678-392-3100 Fax: +1-678-392-3101 www.ortec.com Pharmaceutical Containment Technologies Table #60 1530 S. Second St., Suite 200 St. Louis, Missouri 63104 USA Tel: +1-314-776-1119 Fax: +1-314-772-4466 www.pctamericas.com Contact: Brian Logsdon brian@pctamericas.com PCT is a value-added supplier of containment products for use in today’s Pharma, Bio-tech and Chemical industries. Pharmadule Platinum Sponsor Table #49 500 Hills Dr., Suite 120 Bedminster , New Jersey 07921 USA Tel: +1-908-470-1023 Fax: +1-908-470-1024 http://www.pharmadule.com Contact: Camilla Sivertsson camilla.sivertsson@pharmadule.com For more than two decades Pharmadule has specialized in pharmaceutical and biopharmaceutical facility implementation. We are in the unique position of being able to offer our clients absolute, industry-specific solutions at every stage of development. We offer total solutions, from process engineering and architectural design, through commissioning and qualification. All facets are developed and delivered by us, so we can ensure your plant’s completion on schedule and on cost. This is achieved through The Power of Certainty. Optima Group Pharma Table #13 1330 Contract Dr. Green Bay, Wisconsin 54304 USA Tel: +1-920-339-2222 Fax: +1-920-339-2233 www.optima-pharma.com Contact: Optima Group Pharma info@optima-usa.com Manufactures cGMP compliant standard and custom filling, closing, processing, and freeze drying equipment for the pharmaceutical industry. 6 Tampa Conference 2010 www.ISPE.org Pharmasystems, Inc. Table #7 662 Goffle Rd. Hawthorne, New Jersey 07506 USA Tel: +1-973-636-9007 Fax: +1-973-636-9603 www.pharmasystemsusa.com Contact: Bernard M. Giletta info@pharmasystemsusa.com Representing: Atec- complete processing of stoppers/caps; SKAN- containment/isolation specialists; Weiler Engineering- blow/fill/seal; Aseptic Technologies - closed sterile vial processing; Eisai- visual and semi-automatic inspection, high speed labeling; Tecnologia Meccanica- state of the art fluid jet micronizing. Saint-Gobain Performance Plastics Table #19 460 Milltown Rd. Bridgewater, New Jersey 08807 USA Tel: +1-908-218-8888 Fax: +1-908-218-9009 www.biopharm.saint-gobain.com High Purity flexible Tubing, single use assemblies, Hose, Piping, tanks and lab ware. SKAN US, Inc. Table #8 2655 Industrial Lane Broomfield, Colorado 80020 USA Tel: +1-630-305-3715 Fax: +1-303-438-1598 www.skan.ch SKAN is the largest supplier of aseptic/potent isolators for production and sterility testing applications for the pharmaceutical/biotech industries. Praqco Table #10 P.O. Box 1320 Gurabo, Puerto Rico 00778 USA Tel: +1-787-737-3077 Fax: +1-787-737-1975 www.praqco.com rommelag USA, Inc. Table #56 27905 Meadow Dr., Suite 9 P.O. Box 2530 Evergreen, Colorado 80437 USA Tel: +1-303-674-8333 Fax: +1-303-670-2666 www.rommelag.com Contact: Tim Kram mail@rommelag.com SNC-Lavalin Table #44 436 Creamery Way Exton, Pennsylvania 19341 USA Tel: +1-610-299-5926 Fax: +1-610-524-2443 www.snclavalin.com/slet SNC-Lavalin provides engineering, construction, process automation, commissioning, and validation services to Biopharmaceutical clients worldwide. So-Deep, Inc. Rommelag® is the inventor and primary manufacturer for Bottelpack® advanced aseptic Blow/Fill/Seal liquid packaging technology. Table #72 8397 Euclid Ave. Manassas Park, Virginia 20111 USA Tel: +1-732-429-9737 www.sodeep.com Contact: Dennis Correll sodeepnj@aol.com Rytec High Performance Doors STERIS Corporation Table #17 One Cedar Pkwy. Jackson, Wisconsin 53037 USA Tel: +1-262-677-9046 Fax: +1-262-677-6516 www.rytecdoors.com Contact: Bill Katschilo swolford@rytecdoors.com Rytec Coporation is the nation’s leading manufacturer of high-performance doors for industrial, commercial, pharmaceutical and colo-storage environments. www.ISPE.org Tampa Conference 2010 Table #20 5960 Heisley Rd. Mentor, Ohio 44060 USA Tel: +1-440-354-2600 Fax: +1-440-350-7081 www.steris.com A world leader in innovative, documented decontamination solutions for research, pharmaceutical production, and Biopharmaceutical markets. 7 TalentWRx, LLC Table #66 4921 Memorial Highway, Suite 100 Tampa, Florida 33634 USA Tel: +1-813-699-5504 Fax: +1-813-884-7060 www.talentwrx.com Contact: Kurt Moore TSI, Incorporated Table #12 500 Cardigan Rd. Shoreview, Minnesota 55038 USA Tel: +1-800-874-2811 Fax: +1-651-490-3824 www.tsi.com Contact: TSI, Incorporated answers@tsi.com TSI offers a comprehensive line of advanced aerosol instrumentation including the “AEROTRAK” hand held, portable and remote particle counters. Veriteq Instruments Table #5 13775 - Commerce Pkwy. Richmond, British Columbia V6V 2V4 Canada Tel: +1-919-414-9812 Fax: +1-604-273-2874 www.veriteq.com Contact: P. Roy Snipes rsnipes@veriteq.com Veriteq Instruments Inc. provides the most reliable environmental monitoring, alarming and validation solutions to the pharmaceutical and biotechnical industries. Visit www.veriteq. com or call +1-800-683-8374. W. Soule & Company Table #58 7125 S. Sprinkle Rd. Portage, Michigan 49003 USA Tel: +1-269-324-7001 Fax: +1-269-324-7950 8 www.wsoule.com Fabrication, construction, and maintenance contractor specializing in orbital welding for high purity process systems. Walker Barrier Systems Table #18 618 State St. New Lisbon, Wisconsin 53950 USA Tel: +1-608-562-7761 Fax: +1-608-562-7762 www.walkerbarrier.com Contact: Gary Partington gpartington@walkerbarrier.com Walker Barrier Systems designs and builds positive pressure isolators for aseptic product testing, processing and filling. Our negative pressure, potent material isolator and glove box experiences range from weighing/dispensing applications to synthesis processes and nuclear applications. WBS is now building Extract Technology down flow booths in the US. Watson-Marlow Pumps Group Tables #41 and #42 37 Upton Dr. Wilmington, Massachusetts 01887 USA Tel: +1-978-658-6168 Fax: +1-978-658-0041 www.watson-marlow.com Contact: Watson-Marlow Pumps Group support@wmbpumps.com Watson-Marlow is the pump of choice in the pharmaceutical and biotech industry. Whiting-Turner Contracting Co. Table #28 300 E Joppa Rd. Towson, Maryland 21286 USA Tel: +1-410-337-5769 Fax: +1-410-337-2147 www.whiting-turner.com Tampa Conference 2010 www.ISPE.org TECH-Knowledgy Session Schedule 23-24 February 23 February Process Specific Containment Design Presented By: Brian Logsdon, General Manager, Pharmaceutical Containment Technologies Time: 10.00 - 10.30, Stage #2 Visit Table #60 for more information on this topic. 24 February Monoblock Concept Presented By: Domenic Imperiale, CAPMATIC LTD Time: 10.00 - 10.30, Stage #1 Visit Table #31 for more information on this topic. Exhibit Schedule Monday, 22 February 07.30 – 18.30 Exhibitor Registration/Information Open 12.00 – 16.30 Exhibitor Set-Up 17.00 – 18.30 Exhibits Open – Opening Reception in the Exhibit Hall Tuesday, 23 February 07.00 – 17.00 Exhibitor Registration/Information Open 07.30 – 09.00 Continental Breakfast in Exhibit Hall 07.30 – 16.00 Exhibits Open 10.00 – 11.00 Networking Refreshment Break in Exhibit Hall 10.00 – 10.30 TECH-Knowledgy Session – “Process Specific Containment Design” Presented by: Pharmaceutical Containment Technologies - Exhibit Hall Stage #2 12.00 – 13.00 Lunch 14.30 – 15.30 Networking Refreshment Break in Exhibit Hall Wednesday, 24 February 07.00 – 17.00 Exhibitor Registration/Information Open 07.30 – 09.00 Continental Breakfast in Exhibit Hall 07.30 – 16.00 Exhibits Open 10.00 – 11.00 Networking Refreshment Break in Exhibit Hall 10.00 – 10.30 TECH-Knowledgy Session – “Monoblock Concept” Presented by: CAPMATIC LTD Exhibit Hall Stage #1 12.00 – 13.00 Lunch 14.30 – 15.30 Networking Refreshment Break in Exhibit Hall 16.00 – 17.00 Exhibit Tear Down *Exact times are subject to change. www.ISPE.org Tampa Conference 2010 9 Thank You to Our Sponsors! Onsite Advertising Host Internet Sponsor Platinum Lanyards and Hotel Key Cards Exhibit Hall Floor Plan TECH-knowledgy Session #1 (Audubon Ballroom) Entrance TECH-knowledgy Session #2 Entrance 10 FOYA Internet 66 Career Cafe’ Talent WRx Tampa Conference 2010 www.ISPE.org www.ISPE.org/advertise What can ISPE do for you? Reach tens of thousands of pharmaceutical manufacturing industry professionals around the globe through advertising your brand in ISPE’s Pharmaceutical Engineering magazine. Network with key contacts through Exhibit and Sponsorship opportunities. ISPE has proven “best networking events” by our Exhibitors. “… The attendees we connected with were really interested in a business connection. The contacts that we made were solid and substantial.” – Project Manager, Engineer, Nicos Group, Inc. ISPE Milan Congress 22-25 March 2010 Washington Conference 7-10 June ISPE Brussels Conference 20-23 September 2010 Annual Meeting 7-10 November We invite you to learn more about sponsorship or advertising opportunities by visiting www.ispe.org/advertise, or contact a member of our ISPE Sales team. John Phillips Director of International Sales Tel: +1-813-739-2292 Email: jphillips@ispe.org Valerie Adams Sales Associate, North America Tel: +1-813-739-2274 Email: vadams@ispe.org THE OFFICIAL MAGAZINE OF ISPE www.ISPE.org Tampa Conference 2010 11 High performance teams make the difference. Commissioning Agents. Our teams are recognized industry leaders in developing better methods to meet your business and regulatory demands. When schedule is your problem, we are your solution. Major Services Include: Commissioning planning equipment start-up, troubleshooting, and field execution; verification and qualification (IQ, OQ, PQ) Quality Risk Management (QRM) Implementation and Risk Based Qualification Programs Commissioning Agents, Inc. Validation - Process, Cleaning, Sterilization, Compu Computer Process Improvement Services: Process Analytical Technology (PAT), technology transfer, process improvement studies Technical services including design reviews, SOP development, training Achieve world class manufacturing. Call Robert E. Chew, P.E., President Robert.Chew@CAgents.com +1.317.710.1530 Maintenance program development and impleme implementation cGMP Compliance Services - audits, regulatory reviews, improvement projects, submission assistance, comparability protocols Commissioningagents.com