www.ispe.org/southcentral Published by the South Central Area Chapter Serving Louisiana, Oklahoma and Texas Chapter Manager: Chris Clarke Phone: 1.816.741.9484 and E-mail: ispesc@aol.com Board of Directors Shannon Goodson; President Cytovance Biologics 405-319-8312 shannonwinters1@gmail.com Mike Mills; Vice President Mundy PharmaTech (281) 530-8711 Steve Pondell; Treasurer Integrated BioTech Solutions 281-253-7088 Amber Myers; Secretary CRB 816-880-9800 Joe Rettinger; Past President CSA Soliance 512-732-1210 ext. 112 Bill Shwaiko; Director Alcon Laboratories, Inc. 817-551-4537 Joe Sullivan; Director Alcon Laboratories, Inc. 817-551-8556 Craig Laubacher; At Large Member CSA-Soliance (512) 732-1210 ext. 113 Chris Clarke; Chapter Manager 816-741-9484 ispesc@aol.com NEWSLETTER December 2012, Number 4 ISPE South Central Chapter DINNER EVENT austin, TEXAS 26 february, 2013 Re-Tasking of Existing Process Equipment The South Central Chapter is sponsoring a dinner event on Tuesday February 26 at the Iron Cactus Restaurant at 10001 Stonelake Rd, Austin, TX 78759. The event will have a cocktail hour, followed by the presentation and dinner. A networking period will follow. The presentation topic is Re-Tasking of Existing Process Equipment and the presenter is Witold Lehmann of CRB Consulting Engineers. The consolidation within the industry has resulted in a growing surplus of high quality equipment that has become dormant or available for resale. Fueled by industry pressures, many organizations are looking to this area as a means to save on two critical areas: cost and schedule. While the benefits are clear, there are pitfalls and challenges that must be recognized and overcome to make such projects successful. In this educational meeting, the speaker will address the practical realities and implications related to the repurposing of existing process equipment as well as how to avoid potential pitfalls with specific guidance and awareness. Important consideration will be given to the facility and continued on page three A Message from the dar and plan on attending. Also, please help to spread the word to any other colleagues or contacts you have that may be interested—especially any new Members. Members and non-members are welcome at the events. president If you are unable to attend this meeting, please check with the website or future newsletters for upcoming dinner/education events in your area. These meetings are a great way to keep up to date with trends and changes within the pharma/bio-pharma industry, along with keeping up with contacts in the area. Other upcoming ISPE events include the Tampa Conference in February, the Baltimore Conference in March and INTERPHEX in April in New York, in addition to numerous other training events and conferences throughout the year. I invite you to visit the ISPE.org website to see if any of these opportunities would benefit you, your career and your employer, as many of these are highly specialized events, for certain aspects of the industry. Greetings South Central Chapter Colleagues: Happy New Year! It is this time of year that we reflect on the last year and look forward to the next. 2012 brought about some interesting events that affected our industry including the issues with the compounding pharmacies that will lead to a redefinition of that aspect of the industry, among other notable events. I have also been observing a general upswing in the industry as a whole as of late, which is good for all of us! 2013 will hopefully prove to be an exciting and profitable year for all. I would also like to extend a very special welcome to our Young Professionals (individuals just starting in the industry and in their first four years after completing their university education). The South Central Chapter won the award for most Young Professionals recruited from 31 December 2011 to 31 October 2012 among Small Chapters. We are very excited to have more Young Professionals joining our Chapter and I encourage you to attend the events to increase your networking and to get involved with leadership of the Chapter. Please feel free to contact me if you are interested! The dinner education event on October 16 in Dallas was an enjoyable evening and very informative. Jim Grimes, with GenesisSolutions presented on “Asset Management for Operational Excellence”. Olenjack’s Grill in Arlington proved to be a great central location (between Dallas and Ft. Worth) for this event. Our next event will be in Austin on February 26th at the Iron Cactus. Wit Lehman will be reprising his presentation from the 2012 Annual meeting: “Re-Tasking Existing Equipment and Legacy Facilities: The Practical Realities”. Please mark your calen- In closing, I would like to thank you all for your participation in the South Central Chapter. We do have a very geographically broad and industrially diverse chapter and it is all of you who make it unique and enjoyable. I am looking forward to meeting many of you over the next two years of my term as President. Enjoy your 2013! Shannon Winters Goodson www.pspaec.com 2 South Central Chapter DINNER EVENT continued from page one how it interfaces with the used equipment to mitigate equipment installation and operational problems. The discussion will conclude with a case study for a fluid bed processor installation. ect engineering with Novartis Pharmaceuticals (formerly Sandoz) and worked five years for an M/E consulting firm prior to his employment at Novartis. Witold Lehmann, P.E. is a Senior Process Engineer for Clark, Richardson and Biskup Consulting Engineers, Inc. (CRB) with over 25 years of experience focusing on pharmaceutical facilities design and related process equipment operations for oral solid dose manufacturing operations. Prior to his work at CRB, he had over 11 years of experience in process and proj- The registration form is in this newsletter and is also posted on the South Central Chapter Website at http://www.ispe.org/south-central-chapter . Send your registration form with a check payable to ISPE South Central Chapter to the Chapter Manager: Chris Clarke 8601 N Overland Drive Kansas City, MO, 64154 For more info, call Chris at (816) 741-9484 or ispesc@aol.com. astropak.com sixlog.com keith.kettler@.crbusa.com www.crbusa.com www.meco.com 3 John.Hannon@CAgents.com Tony.Thompson@CAgents.com WWW.COMMISSIONINGAGENTS.COM www.propharmagroup.com 4 www.masy.com www.reesscientific.com ispe international Events 25-26 February 2013 Critical Utilities 2-Day Education Intensive Tampa, FL 3-6 November 2013 ISPE Annual Meeting Washington, DC 5 ISPE Announces 2012-2013 Board of Directors Election Results (TAMPA, FLORIDA, USA, 17 OCTOBER 2012) – ISPE has announced the results of its 2012-2013 International Board of Directors election, revealing a slate of representatives that hail from nearly every corner of the globe. “2013 will be a year of continued transformation for ISPE, as we align our traditional position as the pharmaceutical industry’s neutral ground upon which to resolve technical issues with a necessary transition to a focus that encompasses the complete product lifecycle,” said ISPE President and CEO Nancy Berg. “I am confident that the incoming International Board of Directors will build upon the work of previous Boards and the Society’s past success to lead ISPE in its mission to help advance the pharmaceutical industry’s efforts to provide safer, more affordable and more available drugs for patients around the world.” The following pharmaceutical industry professionals have been elected to positions on the 2012-2013 ISPE International Board of Directors: Officers • Chair: Charlotte Enghave Fruergaard, Director of Technology/Process, NNE Pharmaplan Denmark. • Vice Chair: Damian Greene, Senior Director Network Strategy, Pfizer Global Supply. • Treasurer: Brian H. Lange, PE, Operations Director/PMO, North American Operations and Merck Consumer Care, Merck & Co, Inc. • Secretary: Andrew D. Skibo, Executive Vice President, Operations, MedImmune. • Past Chair: Arthur “Randy” Perez, Director, IT Risk Management and Compliance, Novartis Pharmaceuticals. Re-elected Directors: • Joseph Famulare, Senior Director, Global Quality Compliance and External Collaboration, Genentech. • Gordon Leichter, Eastern Regional Sales Manager, Belimed. New Directors: • Mike Arnold, Senior Director, Strategic Partnerships, Pfizer. • Jennifer Lauria Clark, CPIP, Technical Services Project Manager, Commissioning Agents, Inc. • Jim Durkin, Project Manager, United Kingdom National Health Service. In addition to those named above, Directors James A. Breen, Jr., PE, LEED AP, Tim Howard, CPIP, PE, Doyle R. Johnson, Morten Stenkilde, and Udo J. Vetter, each of whom were elected in 2011 to serve a twoyear term, will continue their service on the Board. Complete biographical information on all of ISPE’s Directors can be found at the ISPE Board of Directors web page. About ISPE ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA and offices in Brussels, Belgium, Singapore and Shanghai, China. Visit www.ISPE. org for more information. For more information contact: Danielle Hould ISPE Communications Manager Tel: +1-813-960-2105, ext. 277 email: dhould@ispe.org www.ISPE.org 6 ISPE South Central Chapter DINNER EVENT austin, TEXAS attendee Registration FORM 26 february, 2013 The event will be held ISPE Membership #__________________________ at the Iron Cactus Restaurant Name______________________________________ at 10001 Stonelake Rd. Company___________________________________ Address____________________________________ City/State/Zip________________________________ Austin, TX 78759 (512-794-8778) www.ironcactus.com Phone_____________________________________ Fax________________________________________ Presentation E-mail_____________________________________ The speaker will be: Witold Lehmann of CRB Consulting Engineers Additional Attendees: 1. ________________________________________ 2. ________________________________________ Our presentation topic will be: Re-Tasking of Existing Process Equipment Registration Fees Member $ 40 x______= $______ Non-Members $ 55 x______= $______ Student $ 20 x______= $______ Vendor Table $ 500 x______= $______ Schedule of Events Dinner Sponsor $ 300 x______= $______ Social Hour Sponsor $ 250 x______= $______ Total Amount Social Hour/Networking 6:00 PM Presentation 7:00 PM Dinner 8:00 PM Networking 8:00 PM $______ Payment Method: Pay at the Restaurant & Register in Advance by February 13th, 2013 to Chris Clarke, Fax: (816) 746-1989 • Phone: (816) 741-9484 ispesc@aol.com 7