The PDA Southeast Connection Southeast Chapter Connecting People, Science and Regulation Officers From the PDA Southeast Chapter President... Dear Members of the PDA Southeast Chapter, President Patrick Sabourin With summer coming to a close, and 2009 approaching Novartis Vaccines and Diagnostics faster than some of us would like, I’d like to summarize Office: +1 (919) 577-5122 some of the significant events that took place within PDASE [email protected] so far this year. Vice-President Michele Creech In March of this year, Diane Williams chose to step down Talecris Biotherapeutics as our association manager. PDASE interviewed several Office: +1 (919) 359-4162 [email protected] management companies and chose Blue Stare Services out of Chapel Hill, North Carolina. Blue Star Services is owned Secretary Beth B. Meinig and operated by George and Debora Steenson. Many of you Integrated Compliance Consulting, have already met them as they were present at our Spring Inc. Conference this March, and they organized our Golf Social Tel: +1 (919) 612-9522 [email protected] in June. Treasurer Bruce Craven Our Spring Conference took place at the Biotech Center in BE&K BioPharm RTP and, was well attended. Many vendors displayed their Tel: +1 (919) 462-6021 [email protected] products and services. A sit down lunch was provided and sponsored by Accugenix, a proven supporter of PDA South- Past President Lisa Eklund east. I’d like to extend a big thank you to all the vendors Purdue Pharmaceuticals LP that came out to support this function, as well as all the Tel: +1 (252) 265-1953 PDASE members, and Ta-Mela Jeffries from PDA national. [email protected] Our Golf Social took place at Lochmere Golf Club where on Upcoming a beautiful sunny day; we had 69 golfers take to the links for a great day of golfing followed by a barbeque lunch. A Events drawing for prizes was conducted during lunch, and I’m pleased to say, everyone walked away with a gift, memo- 2008 Fall Conference continued on page 4 & Vendor Show September 23 In this issue Awards Reception PDA Southeast Chapter 2008 Fall Conference Registration Around the Job Market December 8 Golf Social Highlights Committee Chairs Program Committee Chair David M. Charron Clarkston Consulting Tel: +1 (919)609-3901 [email protected] Sponsorship Committee Chair 2008 Fall Conference Hal Sanborn PharmaSys, Inc., & Vendor Show Tel: +1(919) 468-2547 [email protected] Communications Committee Chair Angel Colucci Commissioning Agents, Inc. September 23, 2008 Tel: +1 (919) 753-6227 [email protected] Philanthropy Committee Chair Shelley Preslar The NEW Downtown Invensys Validation Technologies Tel: +1 (919) 616-7793 Marriott City Center [email protected] Raleigh, NC PDA Southeast Chapter c/o Blue Star Services 1829 East Franklin Street Veltek Associates, Inc. Suite 600 Chapel Hill, NC 27514 Brent Watkins Sterile Chemcials pdase@bluestarservices. Southeastern Sales Manager Disposable Garments net 252-266-2159 EM Equipment [email protected] Laboratory Services 919.418.1325 Telephone 919.933.9233 Fax Visit www.pdase.org Innovative Clean Room Solutions 2 Around the Job... 2008 Job Seekers Market B y David G. Smith Area Manager Kelly Scientific Resources Email: [email protected] There is no doubt that the U.S. job market has softened considerably since the beginning of 2007. One does not have to look hard to see frequent announcements of plant closures, reorganizations, and layoffs. There are three specific factors affecting the pharmaceutical and biotech industries today. 1) An unstable investment atmosphere 2) The imminent expiration of several patents for blockbuster drugs, and 3) An increasingly demanding regulatory environment Datamonitor states that drugs earning $140 billion in sales will lose patent protection by 2016. This fact, coupled with harder to obtain financing and the increasing cost of clinical trials, is forcing the industry into a period of change. During this change, the labor trends will be difficult to predict with precision, but we be- lieve that the demand for talented scientists will remain generally high. In the second half of 2008, the employment picture will continue to favor the job seeker. While job searches may take a bit longer, job seekers are apt to find a number of options available. Despite the fact that there may be more layoffs in the upcoming months, we are finding that most affected employees find new positions quickly. However, you will need to consider a few tips when looking for a job: • Network, network, network • Target industry specific job boards (i.e. PDA Website) • Practice interviewing with a friend • Spend the time to create a stellar resume • Treat your job search as a full-time job According to our customers, we will see a continued high demand for chemists (analytical, method develop- ment, polymer, and organic/synthetic), microbiologists, clinical research professionals, and regulatory special- ists. Staffing in manufacturing and quality areas will continue to trend lower as many companies trim costs. While much of “Big Pharma” faces ongoing reorganizations, pharmaceutical companies specializing in gener- ics are hiring in substantial numbers. If you find yourself looking for a job or needing to increase staff, 2008 will prove challenging, but there is reason to be optimistic. Most candidates will need to be more flexible than in the recent past; but, they are likely to have a variety of job op- tions. While there will be slightly more candidates on the market in 2008, employers will continue to struggle to identify skilled scientists. Because the national unemployment rate remains at a histori- cally low 5 percent, overall, employment prospects remain solid. 3 From the PDA Southeast Chapter Members President...(continued) In The News ries of a great day, and a photo of their foursome. Another Thank You is in order. PDASE would like to thank all of our spon- Accugenix, Inc. is proud to announce the sors for helping with this special event. September 4 release of its 2008 Bacterial Without them it could not take place, so Library! The leader in genetic microbial if in your daily activities you see one of identification, Accugenix has tested and them, please take a moment to thank analyzed over 300,000 environmental them for their continued support, and let isolates common to pharmaceutical and them know you look forward to seeing other manufacturing sites. Our library them next year. update includes organisms recently dis- covered and/or previously unidentifiable Please mark your calendars for the PDASE at the species level. Accugenix boasts Fall Vendor Show to be held on Tuesday, the industry’s most comprehensive vali- September 23rd at the new Marriott City dated DNA sequence library, and the Center in downtown Raleigh. This promis- new Bacterial Library marks our contin- es to be a special event you won’t want to ued commitment to providing customers miss. Information regarding the Fall Con- with the industry’s best microbial identi- ference & Vendor Show should have been fication services. FDA-registered, cGMP received. I am looking forward to seeing compliant, competitive global standards. you and your colleagues there. Accugenix—the leader in genetic micro- bial identification. Please visit www.ac- In closing, I’d like to remind you that your cugenix.com/pdase chapter is dependent on the support of its vendors, sponsors and members like you. If you’d like to volunteer for a committee, Griffin Engineeringrecently has moved please contact our Management Company into their new office in Morrisville, NC. at: [email protected]. You can The new office is centrally located in RTP, also contact Blue Star Services with any near RDU airport. The location provides updated information, or questions you RTP clients with immediate support. Their may have. design, commissioning, validation, LEED, energy studies, and NEBB® Certified I sincerely hope you have a safe and happy Test, Adjust, and Balance divisions oper- summer, and I look forward to seeing all of ate from this office. They have added a you at our remaining 2008 events! production area for process skid devel- opment and testing, as well as, a spe- cialized area and equipment for training Patrick Sabourin, President and procedure development for their TAB PDA Southeast Chapter division. Contact Info: JimGriffin@Griffin- Engineering.com If you would like to contribute to the Members in the News, send informa- tion to [email protected] 4 Quality Processes in Manufacturing PDA Southeast Chapter 2008 Fall Conference & Vendor Show Tuesday September 23 The New Raleigh Marriott City Center located in Downtown Raleigh • Educational Sessions • Latest in Technology • Networking Opportunities • Free Parking To Register Online Tokens for Attendees www.pdachapters.org/southeast/ 2008 Fall Conference & Vendor Show Tuesday, September 23, 2008 The NEW Raleigh Marriott City Center Downtown Raleigh, North Carolina You are invited to attend one of the most important events of the year as our special guest, at the PDA SOUTHEAST CHAPTER Fall Conference & Vendor Show. The event will take place at the NEW Raleigh Marriott City Center in down- town Raleigh, North Carolina on Tuesday, September 23, 2008. The PDA Southeast Chaper serves the states of North Carolina, South Carolina, Georgia, Florida, Virginia and Tennes- see. The chapter works to foster and advance the art and science of pharmaceuticals/medical devices/ biotechnology by providing the membership with practical, technical lecture and laboratory education and training in pharmaceutical technology. AGENDA 6:00am-7:30am Exhibitor Setup 7:30am–8:30am Registration/ Exhibitor Hall Opens 8:30am–9:30am Leveraging Statistical Methods and Analysis for Validation Stephen M. Perry, PMP - President, Kymanox The premise of “n=3=validated” is not consistent with the FDA’s 21st Century approach to qual- ity and new global quality systems such as Q10.