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Issues of Concern to Members, Members’ Companies, and Regulatory Leaders, and to Be an Asset in Strengthening Manufacturing Education Worldwide.”

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Issues of Concern to Members, Members’ Companies, and Regulatory Leaders, and to Be an Asset in Strengthening Manufacturing Education Worldwide.” Reprinted from PHARMACEUTICAL ENGINEERING® The Official Magazine of ISPE March/April 2012, Vol. 32 No. 2 Industry Interview www.PharmaceuticalEngineering.org ©Copyright ISPE 2012 Nancy S. Berg took the helm of New ISPE President and CEO Sets the ISPE in January as the new Tone for ISPE’s Work Ahead President and CEO. In the few weeks since her arrival, she has been working to focus ISPE Integrity and Accountability on around its core the World Stage competencies SPE was founded in 1980 by a handful of and key areas people who believed the pharmaceutical for strategic industry needed an organization that would development. deal with practical applications of science Iand technology for technical professionals. Their This article aim was to improve efficiency and best practices introduces in pharmaceutical engineering to ultimately Berg’s view ensure the quality and safety of medicines. on the role Thirty two years and 20,000 Members later, Nancy S. Berg believes it’s time for ISPE to of ISPE and shine its light brighter on the world stage. As an the important independent organization with a Membership link between of leaders, influencers, and decision-makers Members, representing all areas of pharmaceutical manufacturing, Berg says ISPE’s work can help leaders, and support a more positive perception of pharma- staff. ceutical companies and their employees. Now more than ever ISPE can serve as a beacon for an industry at the crux of myriad challenges and higher expectations, said Berg. “Many professionals believe that our industry gets a bad rap, and I think they’re right,” said Berg. “This happens, in large part, because of the importance of the work we do. Our industry more than 20,000 industry professionals are makes products that are life-changing and life- members of ISPE, an organization dedicated to sustaining and they impact hundreds of millions sharing best practices and knowledge to protect of people worldwide. When the cost of a drug the world’s drug supply, is a testament to how increases or there are problems with a new seriously the industry takes its responsibilities. medication, the public feels the consequences. ISPE’s Members are the industry thought lead- In these cases, it’s a natural reaction to assign ers around the systems that support effective blame. Often, it may appear to some members of manufacturing, including Quality by Design, the public that pharmaceutical manufacturing superior process characterization, and rigor- professionals don’t take their responsibility to ous compliance management. Our Members manufacture drugs safely and cost-effectively run contemporary manufacturing operations, as seriously as I know they do.” maintain detailed regulatory understanding, One of my main goals is for ISPE to do a more and highly progressive manufacturing opera- effective job of communicating the high levels of tions across the global supply chain.” integrity and accountability met by pharmaceu- tical companies and their employees,” said Berg. Integrity and Accountability “One of my goals is for ISPE to communicate Behind the Scenes more effectively around how pharmaceutical ISPE leaders and staff are working behind professionals and companies work to protect the scenes on new strategies that continue to the quality and safety of medicine. The fact that elevate ISPE, and that create better quality MARCH/APRIL 2012 PHARMACEUTICAL ENGINEERING 1 New ISPE President and CEO “My vision is for ISPE to focus strategically on the issues of concern to Members, Members’ companies, and regulatory leaders, and to be an asset in strengthening manufacturing education worldwide.” education, publications, and network- ing activities. Meet Nancy Berg According to Berg, three qualities Nancy S. Berg comes to ISPE with a career that has made her uniquely pre- of the most successful associations are pared to help ISPE as it moves forward with a new strategic plan and a new 1) a reputation for good value with a vision of the Society’s role in the global pharmaceutical industry. portfolio of high quality programs, publications, services, and communi- Berg has more than 30 years in technical association leadership, along with cations, 2) a contemporary, inclusive, experience as an entrepreneur and business consultant to commercial and and enjoyable culture, and 3) a rapid non-profit organizations. From 2000 to 2006 she served as executive director/ response infrastructure that is able CEO of the Society of Manufacturing Engineers (SME), where she directed to collaborate effectively in order to the day-to-day operations of the $30-million/year, 200-employee organiza- quickly seize opportunities and com- tion and its worldwide businesses. Areas under her direction included events municate information to its Members and expositions, magazine publishing, technical communities, membership and industry. operations, and the SME Education Foundation. ISPE’s success will be defined and At SME, Berg repositioned and streamlined operations, established a more measured by the growth and influence customer-driven culture and integrated product and market development of its Membership and programs and initiatives. She designed and launched the association’s strategic plan, being known for contributing value to Plan 2010. Berg and her management team were recognized by leading industry. “My vision is for ISPE to focus professional organizations, such as the American Society for Training and strategically on the issues of concern Development and the International Association of Business Communicators, to Members, Members’ companies, for these efforts. and regulatory leaders, and to be an Prior to being selected as SME’s executive director and general manager, asset in strengthening manufacturing Berg was director of expositions, responsible for overseeing 21 domestic education worldwide,” said Berg. trade shows and pavilion events at foreign trade shows. Under her leader- In 2012, ISPE will focus on the areas ship, SME’s tradeshow activities grew exponentially and SME was named a of Knowledge Management and Profes- top 10 trade show management company in the 1997 and 1998 Tradeshow sional Development, Strategic Market- Week Data Books. As a result of Berg’s strategic leadership, SME grew to ing, Membership Development, and have four of the nation’s top 200 trade shows recognized by Tradeshow Regulatory Affairs, and around achiev- Week. During this time, Berg spearheaded joint ventures, partnerships and ing Enterprise Excellence. Plans for 2012 strategic alliances with more than 100 associations, agencies, governments, and beyond will focus on more effective institutions and organizations around the world. processes for capturing, developing, and presenting ISPE’s knowledge through Throughout her career, Berg has been recognized as a ground-breaking leader. a comprehensive technical strategy, During her tenure with SME, she was the youngest person to head a global building on relationships with Regula- engineering/technical organization. She has been named one of Detroit’s “Top tory agencies around the world, and 100 Most Influential Women” by Crain’s Detroit Business and one of Michi- leveraging all the assets and strengths gan’s Top 50 Women by Corp! Magazine. She also received the Women of of ISPE in communication, marketing, Achievement Award, Business & Industry by the YWCA of Western Wayne and relationship development. County Michigan. As an organization, ISPE will be Berg has been engaged in education and business issues at local, state and globally focused in its delivery of national levels. She has been recruited to serve on many government initia- industry knowledge and technical tives involving business, community, development, growth, revitalization content and dedicated in serving as and labor issues. She served on the Board of National Science Foundation- an independent facilitator of issues of sponsored educational coalitions, as well as other boards and committees. interest to companies, regulators, and She is a fundraiser for the Leukemia and Lymphoma Society’s Team in Train- Members. “Our brand will be strong and ing Program cycling events and the March of Dimes. She is a leader in her representative of the men and women church and has served as professional advisor to executives and companies whose lives are dedicated to keeping the across many industries. world’s drug supply safe and effective,” Berg can be reached at [email protected]. said Berg. 2 PHARMACEUTICAL ENGINEERING MARCH/APRIL 2012 Reprinted from PHARMACEUTICAL ENGINEERING® The Official Magazine of ISPE March/April 2012, Vol. 32 No. 2 Next Generation Manufacturing www.PharmaceuticalEngineering.org ©Copyright ISPE 2012 This article presents how Biopharmaceutical Manufacturing in the next generation of the Twenty-First Century – the Next biopharmaceutical facilities can be Generation Manufacturing Facility designed and operated using recent enabling by Mark F. Witcher, PhD and Jeff Odum, CPIP technologies to improve flexibility, decrease COG, and increase throughput of a Background high throughput to reach competitive COGs manufacturing ncreases in product demand, concerns about targets. With increasing in-vivo insights into facility. product quality, reducing environmental product Critical Quality Attributes (CQA) re- impact, Cost-of-Good (COG) pressures, quirements and improving in-vitro analytical and recent technical developments in the protein characterization methods, the critical Ibiopharmaceutical industry have added signifi- path for the development and
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