Patrick Y. Yang, Ph.D., is executive vice president, Product Operations of Genentech, Inc. In this role, he is responsible for Genentech’s Manufacturing, Engineering, Quality, Regulatory Affairs, Process Development, Supply Chain Management, and Manufacturing Collaboration functions. Dr. Yang is a member of the Executive Committee of Genentech, one of the leading biotechnology companies in the world with a market cap of over $80 billion. Dr. Yang joined Genentech in 2003 as vice president, South San Francisco Manufacturing and Engineering, and was promoted to senior vice president of Product Operations in 2004, then executive vice president in 2006. Prior to joining Genentech, Dr. Yang spent 11 years at Merck & Company in various leadership positions including vice president, Supply Chain Management. In this role, he was accountable for the worldwide production planning, procurement, distribution, logistics, management engineering, contract manufacturing, automation and manufacturing support functions for Merck's manufacturing division and manufacturing plants around the globe. Previous to that position, he was Merck's vice president of Operational Excellence and vice president of Asia/Pacific Manufacturing Operations. Prior to joining Merck in 1992, Dr. Yang spent 12 years at General Electric, serving in several research, engineering, technology, and manufacturing leadership roles with increasing scope of responsibilities. Before working for General Electric, Dr. Yang spent five years in aerospace control systems and life support systems R&D with Life Systems, Inc. Dr. Yang is a Board Director of TaiMed Biologics, Inc. Dr. Yang holds a BSEE degree from National Chiaotung University in Taiwan, a Master of Science from University of Cincinnati, and a Ph.D. in Engineering from the Ohio State University.

Tom Van Laar is the Head of Global Technical Operations at Novartis Pharma and a member of the Pharma Executive Committee (PEC) since November 2004. He is responsible for overall manufacturing and supply for the Pharma division of Novartis AG. Technical Operations has an operating budget of $3 billion, 9000 employees and 24 manufacturing sites around the world. Tom Van Laar joined Novartis in 2002 as Vice President Pharmaceutical Operations in Suffern, NY. He came to Novartis from Pharmacia Corporation (formerly Searle / Monsanto) where he held positions of increasing responsibility for the previous 19 years, including Plant Manager, Sr. Director of Manufacturing and Head of Best Practices Office. Tom Van Laar has a BS in Chemical Engineering from Rensselaer Polytechnic Institute, Troy, NY, and an MBA from Northwestern University.

Parimal Desai received his Ph.D. in Biochemistry from Penn State University and M.Sc. and B.Sc. (Honors) in Chemistry from Indian Institute of Technology, Madras and St. Xavier's College, Calcutta, respectively. Dr. Desai joined Medical Research Division of American Cyanamid in January 1990. He is currently Vice President of New Products (TO&PS) where he has assumed the responsibility of leading Wyeth's efforts to deliver robust new products and manufacturing processes through Quality by Design principles and application of process analytical technology (PAT). Before his new role, Parimal was Vice President of Analytical and Quality Science (CPD) providing leadership to a staff of 220 and supporting a portfolio of more than 70 projects. Parimal has provided technical leadership in successful development, registration and launch of MylotargÒ, EnbrelÒ, SonataÒ, RapamuneÒ, ProtonixÒ, TygacilÒ, LybrelÒ, ToriselÒ and other products globally. He has been awarded the Emerald Honors Award, Distinguished Alumnus Award, Heroes of Chemistry Award and Exceptional Achievement Award. He represents Wyeth on the PhRMA Technical Committee.

Dr Beatrice was elected Vice President, Corporate Regulatory and Quality Science by Abbott's board of directors, effective November 1, 1999. Prior to joining Abbott in this position, Dr Beatrice was a Vice President at Quintiles, in Rockville, Maryland. Before joining Quintiles in 1996, Dr Beatrice, a retired Admiral and Assistant Surgeon General in the United States Public Health Service held various executive management positions at the U.S. Food and Drug Administration. He serves on the Executive Advisory Council of The College of Integrated Science and Technology at James Madison University, and is a Principal Visiting Staff Member at University College, London. In addition, he is a charter member of the Food and Drug Administration Alumni Association and a member of the Association of Food and Drug Officials

Ron Guido has 31 years experience in the health care industry with Johnson & Johnson. He has held executive positions in the areas of engineering, operations, sales, product marketing, international marketing, new business development, information technology and general management. He served as a member of the Ethicon Inc. Management Board from 1996-2004. His leadership skills are evident in having served as Vice President in five different disciplines. His current assignment is Vice President, Global Brand Protection and Supply Chain Integrity for the pharmaceuticals businesses of Johnson & Johnson where his group is responsible for anti-counterfeiting programs and policies. Ron has an undergraduate degree in Industrial Engineering and a Masters in Management Engineering. He is Vice Chairman of the Board for a charitable medical organization known as Operation Smile, an advisor to the Rothman Institute of Entrepreneurial Studies at Farleigh Dickinson University and holds three patents for medical devices.

Jim leads the Corporate Environment, Health and Safety group responsible for the full range of EHS programmes, including setting the direction for EHS at GSK and the provision of environment, health and safety governance and support to all operations. Prior to joining GSK in 1983, Jim has worked in the chemical industry and the US Environmental Protection Agency on environmental issues in the areas of research, design, construction, permitting, and enforcement. Jim has an undergraduate degree in chemical engineering, a Masters degree in Environment Health Engineering and another in Management Sciences, and a PhD in Environmental Engineering. He is a registered Professional Engineer in Pennsylvania and Maryland, and is a Certified Quality Manager.

Bernhardt L. Trout, Professor of Chemical Engineering at MIT, is Director of the Novartis-MIT Center for Continuous Manufacturing and Co-Chair of the Singapore-MIT Alliance Program in Chemical and Pharmaceutical Engineering. His research focuses on the development and application of molecular engineering techniques for pharmaceutical and biopharmaceutical processing and formulation. He has published over 70 papers in the area of molecular engineering. Currently, he has a major research effort in developing new technologies for the separation and downstream processing of small molecule pharmaceuticals. Together with Walter Bisson of Novartis and many colleagues from Novartis and MIT, he set up the Novartis-MIT Center for Continuous Manufacturing in June, 2007. Based at MIT, the Center is developing new continuous technologies across the entire spectrum of pharmaceutical manufacturing

Stephen is a Director of Strategic Quality and Technical Operations in Global Pharmaceutical Operations at Abbott Laboratories, a worldwide-diversified health care company, in Abbott Park, Illinois, USA. He received his B.S. in Applied Biology from the Georgia Institute of Technology in 1979, a M.S. in Microbiology from the University of Georgia in 1982, and a B.S. in Chemical Engineering from the Georgia Institute of Technology in 1984. He joined Abbott in 1984 and has been there for 23 years acquiring process development, manufacturing and management experiences. Stephen joined the Strategic Quality and Technical Operations organization in 2008. Previously he was Director of Process Sciences and Engineering, an organization that provided technical support to Abbott’s drug product and substance manufacturing organization. The Strategic Quality and Technical Operations group provides strategic centralized technical support for data analysis, quality technology transfer, risk assessment and management and development of enhanced quality systems.

James (“Jim”) N. Rider, Ph.D. is currently the Vice President of Global External Manufacturing at the Global Pharmaceutical Supply Group (GPSG). GPSG is a unit of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and is responsible for all small molecule pharmaceutical manufacturing for Johnson and Johnson, Inc. In his current role, Dr. Rider is responsible for the evaluation, development and maintenance of all small molecule drug product external manufacturers around the globe. Key tenets to the successful completion of his job include reliability of supply, quality of the product, and cost of the product. Prior to this position, Jim was responsible for supply chain L&A/M&A at GPSG. He has over fifteen years of experience in the pharmaceutical industry in process development/scale-up, troubleshooting, technology transfer, product transfer and validation for all dosage forms. He has also gained significant expertise in developing long term partnerships with many external manufacturers. Prior to joining J&J, Jim held several positions of increasing responsibility at Hoffmann-La Roche

Patricia C. Tway, PhD, is vice president, Regulatory and Analytical Sciences at Merck. She has responsibility for the preparation and support of CMC filings globally for all Merck products, both pharmaceutics and biologics, over the full lifecycle of the product. She also has responsibility for technical analytical support (method development, validation, transfer, troubleshooting) to the site Quality Control organizations. Her organization also provides regulatory oversight to assure that stability and validation guidelines meet current regulatory requirements globally. Most recently Pat has been very involved in the Quality by Design initiative. She is active in PhRMA and is currently a member of the FDA Advisory Committee for Pharmaceutical Science. Pat received her B.A. from Mount Holyoke College and her PhD in analytical chemistry from Seton Hall University. Dr. Tway has spent her entire career at Merck, working extensively

Barry Rothman is a senior Compliance Officer in the Division of Manufacturing and Product Quality, Office of Compliance, Center for Drug Evaluation and Research (CDER), Food and Drug Administration. Since coming to CDER in 1991, his duties have included the development of guidance and policy relating to the Current Good Manufacturing Practice (CGMP) regulations, and the management of agency enforcement actions involving violations of the CGMP regulations. Mr. Rothman started his career in 1974, in FDA’s New York District, where he specialized in CGMP inspections of the drug and medical device industries. Mr. Rothman has received numerous awards for his work over the years, including the U.S. Department of Health and Human Services Secretary’s Award for Distinguished Service and the FDA Commissioner’s Award for Outstanding Service.

Emil W. Ciurczak has advanced degrees in Chemistry from Rutgers and Seton Hall Universities and has been in the pharmaceutical industry since 1970 (Ciba-Geigy, Sandoz, Berlex, Merck, and Purdue Pharma), performing method development on all types of analytical equipment. In 1983, he introduced NIR spectroscopy consulting for Technicon (Bran & Leubbe), NIRSystems (FOSS), CDI Pharma, Infrared Fiber Systems, Brimrose, and Buchi. Most research was on pharmaceutical applications of NIR where he has published over three dozen articles in refereed journals, over 150 magazine columns, and presented nearly two hundred technical papers. Emil is a Contributing Editor for Pharmaceutical Manufacturing magazine (and Spectroscopy; 1987-2007). He has written and edited several texts and chapters: “Handbook of NIR Analysis” (1st, 2nd, and 3rd editions), “Pharmaceutical and Medical Applications of NIRS” (2nd edition in progress), “Molecular Spectroscopy Workbench,” and chapters on NIR applications to life sciences. Emil sits on several magazine editorial boards, is active in SAS, is a founder of the Council for NIRS, and was the 2002 chair for IDRC (Chambersburg Conference). He has been teaching since 1979: Stevens Tech, College of St. Elizabeth, Hood College, and Mount St. Mary’s College; short courses (in NIR and PAT/QbD) for the ACS, CfPA (US and Europe), SPIE, ASSA, and other organizations. Emil is a consultant in the field of NIR (lab and process applications) and holds nine patents for NIR-based devices and software. He consults with various pharmaceutical companies, instrument manufacturers, and the FDA. He was a member of the PAT sub-committee (Validation) for the FDA and is a member of the PAT Advisory Committee to the USP.

Mark Seitz (Global Supply Chain Manager) supports Lilly’s site and regional distribution operations and directly contributes to a variety of strategic logistics projects. Mark leads Lilly’s Global Logistics Lead Team, and spends considerable time assisting Lilly’s Anti-Counterfeiting Office, US B2B operations, and Government Affairs professionals in distribution related issues such as product serialization, importation, and emerging national and state pedigree laws. He has participated on a number of PhRMA and HDMA committees and is a long time instructor of APICS Supply Chain certification courses. Mark also serves on the editorial board for Pharmaceutical Commerce magazine.

Paul Hesselschwerdt, President of Global Partners, Inc., has been a senior executive in the consulting and management development field for more than 20 years. During that time he has developed substantial international experience working with global companies in the Americas, Europe and Asia to help them to develop their organizations, and improve and grow their businesses on a global scale. Together with the Global Partners team of senior consultants, he has designed, developed, and implemented business change and development programs in sales and marketing, leadership and management development, and project management to thousands of managers from over 100 countries in the Americas, Europe, and Asia. Mr. Hesselschwerdt has worked with Fortune’s “Global 500” companies in a range of industries, including automotive, pharmaceutical, biotech, chemicals, consumer goods, electronics, engineering, high technology and medical devices. His clients include Merck, Serono Biotech, Soitec, ST Microelectronics, Crane Co., Schneider Electric, Gemplus, Imation, DSM Chemicals, AB Electrolux, Wolters Kluwer Healthcare and KONE Elevators. Background Mr. Hesselschwerdt is a frequent conference speaker and author of many articles and papers on strategy deployment, performance measurement, change management and business improvement concepts and methods, including the implementation of Voice of the Customer and Six Sigma in Sales and Marketing organizations. Among his publications is an article in the May 2006 edition of Velocity magazine entitled “How Aligned is Your Organization on the Needs and Methods for Creating Value.” Mr. Hesselschwerdt received a B.S. in finance from Boston University and an M.B.A. from Babson College.

Vice President Statistical Applications

William Botha is Director of Pharmaceutical Manufacturing at the Los Angeles facility of Baxter Bioscience, the first, largest, and most modern plasma fractionation facility in the world. He is responsible for approximately $ 400M of production revenue, overseeing a staff of 200 reports. William has an extensive background in lean initiatives, from Director of Lean Enterprise at Rockwell Automation, to Lean Master in 2004 at Baxter Bioscience, where he was responsible for rolling out lean principles across Europe and the U.S. In 2006, he was appointed as the Director, Pharmaceutical Manufacturing at the Los Angeles site, where he created the structure and management systems for the business unit, and alongside his Quality partner, has reduced the average lead times and their standard deviations by significant amounts in just eight months. Customer fulfillment has improved by more than fifty percent across all product families while discards, costs and deviations have also dropped. A dynamic and inspiring speaker, he has presented the tricks and traps of effective, high impact change to industry audiences worldwide.

Sherman is the Director of Materials Management of Sanofi Pasteur Limited. His responsibility covers Production Planning, Logistics and Distribution, Customer Services, and Supply Chain Systems and Improvement. Before joining Sanofi Pasteur, Sherman worked at various senior supply chain and operations management positions for several Fortune 100 multi-national corporations, such as The Dow Chemical Company, Sea Land Service Inc. at different geographical locations. Sherman is a pioneer in leading re-engineering on both Supply Chain and Cold-chain Management and achieved many break-through improvements. His unique integrated approach on cold-chain management helps Sanofi Pasteur Ltd. achieved close-to-zero deviation performance for years. Sherman possesses MBA and Industrial Engineering degree. He is also members of several supply chain professional associations of Planning, Logistics and Purchasing.

Mike Randolph has 17 years experience in the pharmaceutical and medical device industries with both Baxter Healthcare and Teva Pharmaceuticals USA. He has held positions in the areas of engineering, manufacturing, packaging, plastics, quality assurance, and operations. Mike began his career with Baxter where he was the project manager whose responsibilities included site selection through the start-up of four small device facilities. He also spent five years at Baxter’s flagship IV solutions plant (North Cove, NC) in various manufacturing/packaging roles and spent several years as the quality assurance manager for the filling/packaging operations. While in this role, Mike was a member of the team that helped the North Cove plant to win its first Shingo award (they later won a second award). In 2001, Mike joined Teva Pharmaceuticals USA managing the liquids, creams, ointments and solid dosage packaging operations. His current assignment is Sr. Director of Manufacturing Operations for the Sellersville plant. This facility is one of eight strategic manufacturing sites within Teva and is a complex, high mix, lower volume manufacturing site. Mike has undergraduate and Masters degrees in Civil Engineering.

Hussain Mooraj brings more than 15 years of experience in manufacturing, supply chain, life sciences consulting, strategic consulting and strategic marketing to his role as Vertical Lead of the Healthcare & Life Sciences practice at AMR Research. He works closely with executives from companies across the healthcare value chain advising them on operational and technology best practices. Prior to joining AMR Research, Hussain was heading the program management, marketing and business development functions for Trinity Partners LLC and Trinity Pharma Solutions LLC, firms specializing in strategic consulting and technology-based data management solutions for global pharmaceutical and biotech companies.  Hussain also worked as an engagement lead at Internet strategy consultant Zefer Corporation. While there, Hussain helped Fortune 500 companies develop their B2B and technology strategies.Hussain founded two global textile companies where he served on the Board of Directors and was responsible for manufacturing & sourcing, new product development, and global sales and marketing.Hussain earned his BS in textile management, with honors, from Clemson University/Textile University of Pakistan. He also holds an Engineering MS in Information Systems, an MBA, and a graduate certificate in Supply Chain Management from Northeastern University.

Mr. Kontnik leads Amgen’s Brand Protection program, a part of the company’s Operations Risk Management function. In this role he developed and leads the company’s functionally based global program responsible for fighting illegal counterfeiting, diversion and other brand attacks. This management system, made up of a set of durable, scalable business processes, protects the company’s patients, products and brands. He also leads the company’s serialization and pedigree activities. Mr. Kontnik helps to lead the biopharma industry’s anticounterfeiting activities including the PhRMA International Anticounterfeiting Committee (Vice Chair), Supply Chain Security Work Group, BIO Anticounterfeiting Committee (Chair) and the WHO IMPACT effort. Mr. Kontnik has been working to solve the global pharmaceutical counterfeiting problem for more than 15 years. He is a co-author of Counterfeiting Exposed (Wiley, 2003), Protecting Medicines: A Manual of AntiCounterfeiting Solutions (Reconnaissance, 2002). He served as a founder and chief technical consultant to the www.SafeMedicines.org partnership, consulted with the US Food and Drug Administration, World Health Organization and has spoken internationally on a various anticounterfeiting topics. He is a member of the Washington, D.C. bar.

Dave Rowlands is an accomplished General Manager and corporate strategist, with 20 years experience leading worldwide operations, turnarounds, and key strategic initiatives. Dave is also widely recognized as a thought leader in Strategic Lean Six Sigma. He has led very large, complex deployments in every function of a company, generating in excess of $150M profit annually. He led several major projects during the Xerox turnaround, resulting in more than $200M in cash. The author of 2 best selling books on Lean Six Sigma- What is Lean Six Sigma? (McGraw Hill, 2003) The Lean Six Sigma Pocket Toolbook (McGraw Hill, 2004) - he is frequently invited to speak at the Lean Six Sigma Summit and conference Board on Growth and Innovation.

Eric Fallon, Ph.D., is Associate Director of Manufacturing Sciences and Technology at the Oceanside Product Operations of Genentech, Inc. Genentech’s mission is founded on using human genetic information to discover, develop, manufacture and commercialize biotherapeutics that address significant unmet medical needs. In this role, Dr. Fallon is responsible for process technical support of Oceanside’s plant operations, technology transfer projects into the Oceanside facility, and identification and implementation of continuous process improvement opportunities. Dr. Fallon joined Genentech in 2005 as the head of the newly-formed Oceanside MSAT department. Prior to joining Genentech, Dr. Fallon spent 6 years at IDEC/Biogen IDEC in various roles within process development, scale-up, and technology transfer. Dr. Fallon holds a BS – Chemical Engineering degree from U.C. Berkeley, a Master of Science in Chemical Engineering Practice from the Massachusetts Institute of Technology, and a Ph.D. in Chemical Engineering from the Massachusetts Institute of Technology.

Mike Celentano is the Associate Director, Supply Chain systems at Purdue Pharma, a mid-sized pharmaceutical manufacturer operating several production and distribution facilities. Mike brings extensive experience in both the business and information systems sides of supply chain operations having also worked for 10 years in a similar capacity for the U.S. Surgical division of TYCO Healthcare. He has been an integral part Purdue’s pioneering RFID accomplishments, including the RFID-labeling of individual bottles of pharmaceutical product and the successful piloting of an RFID-based e-pedigree deployment. Most recently, Mike and his team have completed an ambitious RFID Program expansion wherein UHF Gen2 technology has been integrated for the first time into both item and case packaging across Purdue’s domestic OxyContin bottling operations. Mike’s real-world experience has resulted in valuable lessons learned in the practical application of RFID unit-level tagging as pertains to tags and hardware, quality assurance, EPC data collection and management, track-and-trace strategy, and ERP system implications.

Jonathan is currently the Director of Continuous Improvement for TEVA Pharmaceuticals USA where he is responsible for improvement projects for USA operations in PA, NJ and Fl. He joined TEVA Pharmaceuticals in 2001 and has held positions in project management, materials management, and operations. With these positions, Jonathan has served as champion for Lean Sigma initiatives in the Sellersville, PA manufacturing facility. Prior to joining Teva he was with Bausch & Lomb in Rochester, NY, where he held positions in engineering, product development, and operations. Jonathan has an undergraduate degree in Mechanical Engineering from Rochester Institute of Technology, Rochester, NY and a Masters in Business Administration from the University of Phoenix.

Steve Pondell is the Director of Manufacturing for Encysive Pharmaceuticals in Houston. His role at Encysive is to establish and manage the supply chain of the company in the production and distribution of their new small molecule drug, Thelin. Thelin has been approved in Europe, Canada and Australia, and is awaiting approval in the US. Steve has been heavily involved in the manufacturing, regulatory preparation and compliance inspection arenas during the product review process. He has been with Encysive for four years, having spent the prior year as Vice President and Site Manager at Cambrex Corporation in Charles City, Iowa. Steve spent the first 22 years of his career at Abbott Laboratories in North Chicago, Illinois, where he various positions heading up pilot plant and full scale commercial operations, quality assurance and control departments, and engineering. Steve earned his Chemical Engineering degree from the University of Michigan and his MBA from the Lake Forest Graduate School of Management.

Maura has served a variety of roles and functions during her 26 years at Abbott Laboratories. She started her career in the engineering development program, rotating in assignments in four different divisions of Abbott. She then held various positions in engineering and engineering management in Abbott’s Hospital Product division and Corporate Engineering division. After a 2-½ year leave of absence to stay home with her children, Maura changed directions and worked in the commercial operations side of the business, first in Licensing and Business Development in the Chemical Manufacturing division then in the International Division in a marketing role. In 2001, she combined all of her previous experiences and led the team to develop a Global Manufacturing Strategy for Abbott, which let to the creation of a new division of Abbott, Global Pharmaceutical Operations. In the new organization, Maura held the position of Director, Program Management, Licensing, and RSO for 3 ½ years, prior to her current position as Senior Director, Supplier Management. Maura holds a Bachelor of Science degree in Chemical Engineering from the University of Texas at Austin.

Mr. Fecteau is Chairman of SOLABS’ board since 2002. In February 2005, he joined the management team as CEO. Richard Fecteau has 20 years of experience in the pharmaceutical industry. Before joining SOLABS, he was Senior Vice-President of Confab Laboratories, a GMP contract manufacturing organization (CMO) located in Canada. Prior to Confab, he held the position of Vice-President and General Manager of Invensys Validation & Pharmaceutical Solutions, a company of Invensys plc. Under his leadership, the company saw its operations quadruple in size in less than 5 years. As CEO, Mr. Fecteau brings valuable experience regarding business development, administration, and human resources’ management, in addition to his deep knowledge of GxP environments. Mr. Fecteau earned his Bachelor of Science degree in Industrial Engineering from l’École Polytechnique de Montréal, in Canada, and graduate from executive business school at McGill (Management) and Queen’s University (Finance). He is a member of Québec’s engineering Order, and a certified Project Management Professional (PMP). Bilingual, Mr. Fecteau’s experience and knowledge of the industry allow him to present keynote speeches in English and French, as well as act a spokesperson for the media.

Dr. Martin joined The Foxboro Company in the 1970’s and has worked in a variety of positions in training, engineering, product planning, marketing and strategic planning. He left Foxboro to become Vice President at Intech Controls and also at Automation Research Corporation before returning to Invensys in 1996. Since his return he had been VP of Marketing for Foxboro and Chief Marketing Officer for Invensys Manufacturing and Process Systems prior to moving into his current position. He has authored numerous published articles and technical papers and has written two books: Bottom Line Automation and Dynamic Performance Management: The Pathway to World Class Manufacturing and is a contributing author to A Guide to the Automation Body of Knowledge. Dr. Martin holds multiple patents including the patent for Dynamic Performance Measures, Real-Time Activity-Based Costing, Closed-loop business control, and Asset and Resource Modeling, which are the basis for Fortune recently naming him a Hero of U.S. Manufacturing. He was also recently named as one of the 50 Most Influential Innovators of All Time by the Instrument, Systems and Automation Society (ISA). Dr. Martin has BA and MS degrees in Mathematics and an MA degree in Administration and Management, a Master of Biblical Studies degree, a Ph.D. in Industrial Engineering, and a PhD in Biblical Studies.

Lars Gabe is the CEO ICE A/S as well as Chairman of CoP - Operating Efficiency, ISPE Nordic. He will be discussing how many of the tools of Lean Manufacturing are challenging to implement in a regulated, pharmaceutical production environment. Kanban management becomes non-trivial when full batch tracing is necessary. Continuous improvement is costly when it requires large amounts of documentation to be updated. Small batch sizes are inefficient when the quality control overhead is fixed. The right approach and choice of IT systems can help overcome these and other obstacles to traditional Lean Manufacturing principles. Learn how to utilize the benefits, not only the costs, of electronic batch records in weeks, not years. Focus new projects on the premise of continuous improvement, use the experience earned to improve existing production, not only future projects. Use the information in current IT systems for getting the complete overview of the value stream, focusing the attention on the problematic areas. Using electronic batch records and review by exceptions can greatly reduce the quality control overhead. Using electronic kanbans can assist implementation of pull planning while keeping existing batch tracing mechanisms.

Mr. Michael Bruckheimer is an Executive Director, Group Quality Operations with Novartis Pharmaceuticals Corporation, headquartered in East Hanover, NJ. He serves as the corporate FDA Compliance Liaison for all of the Novartis companies. Mike is responsible for the compliance interface with the U.S. FDA in matters related to inspections – planning phases, interactions during inspections and outcomes. He provides support and advice to all internal operations where there is a potential compliance impact on Novartis. He also participates as the Novartis liaison in many domestic and foreign FDA inspections. He is also available to provide advise concerning compliance regulatory issues for all of the Novartis companies. Prior to joining Novartis Mike had a career at the FDA as both a Compliance Officer and Investigator with both the New York and New Jersey District Offices. He has also held many professional positions and a licensed practicing pharmacist.

As the president of Tefen USA, Barry Calogero brings more than 20 years of management experience to the company. He is responsible for setting the direction for the organization, driving profitable growth internally and customer successes across our client base. He directs all activities within North America as well as Asia in all manufacturing and service industries, including life sciences, general manufacturing, semiconductor, hospitals/healthcare, and federal government. Barry has an extensive background in all aspects of product and service optimization with significant operations management consulting solution delivery in both manufacturing and product development environments. With direct experience in automotive, aerospace, electrical control products, and life sciences, he has worked for and with industry leading firms, including Schneider Electric, General Motors, Ford Motor Company, Massachusetts General Hospital, Baxter Healthcare, Boeing Company, Lockheed Martin, and Pfizer, to name a few. Barry holds an Executive M.B.A. from The George Washington University and a bachelor’s degree from Loyola College in Maryland. He is a member of the Young Presidents’ Organization and is an officer for the Washington D.C./Baltimore Chapter.

As Vice President of Statistical Applications, Doug helps clients understand statistical methods and implement InfinityQS software in diverse environments and challenging situations. Prior to joining InfinityQS in 1997, Doug began his statistical career on the manufacturing shop floor at Boeing Aerospace and spent several years working as a statistical consultant to Fortune 500 companies. Doug earned a Bachelor of Science degree in Industrial Statistics from the University of Tennessee, Knoxville in 1987. He has co-authored two books on statistical methods: Innovative Control Charting (ASQ Quality Press, 1997) and Quality Management in Health Care (Jones and Bartlett Publishing, 2000). Additionally, Doug is a bi-monthly columnist for Quality Digest’s Quality Insider and a long standing member of the American Society for Quality.

Sean Diver is Vice President, Sales & Business Development of Dr. Reddy’s Laboratories. In his role, he is responsible for the Custom Pharmaceutical Services (CPS) business in North America. CPS is Dr. Reddy’s dedicated business that provides development and manufacturing services for both bulk as well as dosage products specifically for innovator organizations. Sean joined Dr. Reddy’s Laboratories in 2007 and has been leading the NA Sales & Business Development team since that time. Prior to joining Dr. Reddy’s, Sean was an Associate Director of Sales & Business Development for Lonza, Inc, where he was a responsible for managing key, strategic accounts for the Lonza Custom Manufacturing business unit wherein he supported custom services for both small and large molecule development and manufacturing. Prior to his time at Lonza, Sean spent nearly 12 years with Merck & Co., Inc. in a variety of engineering, manufacturing and procurement positions. In his last position at Merck, Sean was part of the Strategic Outsourcing organization within the Merck Manufacturing Division’s Global Procurement organization. There he was responsible for supplier selection and commercial coordination for products that were outsourced to third parties. Sean holds a BS in Chemical Engineering from Lehigh University, and is currently pursuing a Master of Science in Organizational Dynamics from the University of Pennsylvania.