Currently teaching:
Quality Systems for Regulatory Compliance
Capstone
Carol Beirne has over 27 years of experience at Abbott Laboratories in a variety of quality leadership roles, most recently as a senior manager in the Corporate Quality Organization. She has worked in both the pharmaceutical and medical device product areas. Beirne designed the management review procedure for the Diagnostics Division and represented the process and data to both internal and external auditors, including ISO and FDA. She has a bachelor of science in engineering that allowed her to be extensively involved in process improvements throughout her career. She led a division Quality Training staff in the Global Pharmaceutical Research and Development organization with employees in both Germany and the US. She has an ASQ Quality Manager/Operations Excellence Certification and has served in multiple roles in CAPA investigations. Beirne earned her International MBA from Keller Graduate College of Management.
EMAIL CAROL BEIRNE
Currently teaching:
Risk and Decision Management
Stanley Bouma is a senior manager of R&D Risk Management in Abbott Laboratories molecular diagnostics division and is responsible for maintaining risk management as an integral part of the Quality System. He joined Abbott in 1982, and has had experience in research, technology assessment, validation quality, product development, and risk management. He has presented on risk management at national conferences. Before joining Abbott, he was a research associate at MIT. Bouma received a PhD in chemistry from Stanford University. He has 14 patents.
EMAIL STANLEY BOUMA
Currently teaching:
Risk and Decision Management
Risk and Decision Management
Robert Lechton is a senior quality manager at Baxter Healthcare, where he is responsible for quality compliance for medical products including areas of design control, risk management, and life cycle management. Lechton has been involved in all aspects of product development from early concept, to product launch, and throughout the management of fielded products. He previously was the quality manager for Bosch Rexroth’s Electric Drives and Controls division. Lechton received a MS of Engineering from University of Maryland with a focus on reliability engineering and risk management and a BS in Electrical Engineering from Bradley University.
EMAIL ROBERT LECHTON
Currently teaching:
Quality Systems for Regulatory Compliance
Practical Quality Management
Drug and Biologics Regulations
Pamela Mason is currently the executive vice president for Mason Professional Services, LLC, an independent consulting organization that performs audits, inspections and compliance training for the pharmaceutical, biotech, academic and medical device industries. She is currently the quality and compliance consultant for Northwestern’s Global Health Foundations. Her past positions include training manager, Quality Assurance & Regulatory Affairs for GE Healthcare, director of quality assurance for Radiant Development, as well as quality management roles for PriceWaterhouseCoopers, MGI Pharma, Takeda Pharmaceuticals and G.D. Searle/Pharmacia. Mason currently holds four certifications from the American Society for Quality (ASQ): Certified Quality Auditor, Certified Manager of Quality/Operational Excellence, Certified Software Quality Engineer and Certified Six Sigma Green Belt. Mason holds a master's degree in public health from the University of Illinois at Chicago.
EMAIL PAMELA MASON
Currently teaching:
Healthcare Regulatory Environment
Healthcare Regulatory Environment
Elizabeth Zurek has practiced health care law for over twenty years, including several years with the health law department of a large Chicago based corporate law firm. For the past 16 years, she has served as in-house counsel for several Chicago area health care providers, including academic medical centers and community-based hospitals. Currently, she is in private practice, where she primarily provides services to the in-house legal staff of Northwestern Medical Faculty Foundation and Cadence Health. Her broad-based health care practice is concentrated on reimbursement, corporate and regulatory/compliance issues. In her capacity as general legal advisor to several non-profit health care providers, she regularly counsels individuals at all levels of the organization, including senior management and clinical personnel, about their legal obligations and practical methods of ensuring compliance. Zurek received her JD from Loyola University of Chicago, where she was a member of the Law Review. She is a member of several professional organizations, including the Illinois Association of Health Care Attorneys (for which she served as a director) and the Illinois State Bar Association, where she has been appointed a member of the Health Care Section Council.
EMAIL ELIZABETH ZUREK
Pamela Ransom has been active as an environmentalist, planner, researcher, educator and community activist. For more than eight years she was special assistant for environmental affairs for New York City Mayor David Dinkins. Then she moved into international activism as director of health and environment for the Women’s Environment and Development Organization. She worked closely with the late Congresswoman Bella Abzug, spoke to a variety of UN meetings and international conferences and organized major events at venues such as the Fourth World Conference on Women in Beijing. She has also served on the faculty of Long Island University School of Business, Public Administration and Information. Ransom received her doctorate from Massachusetts Institute of Technology.Gregory Kuhn currently is director of government management consulting at Sikich LLP and was assistant director for public management and training at Northern Illinois University’s Center for Governmental Studies. Kuhn has more than 28 years of combined governmental, consulting and higher education experience. He was the inaugural faculty director of the MPPA program and continues to be program adviser and lecturer. His primary teaching areas include public policy, leadership, public administration and budgeting. He also serves as an instructor/lecturer for Northern Illinois University’s public administration program, and he has earned teaching awards at both NIU and SPS. Kuhn earned an MPA and PhD in public administration, public policy and organizational theory from Northern Illinois University.Andy Sharma is a political economist whose areas of specialty include aging, health disparities, later-life migration and quantitative methods. Currently he works with the Cedar Grove Institute on a project to employ statistical methodology to examine the adverse impact of economic and racial isolation on student performance in North Carolina. A research article from this investigation was published in Education Policy Analysis Archives (Volume 22, 2014) and this study was cited and listed under Table of Authorities in an Amicus Brief filed by the Society of American Law Teachers in the Fisher II case with the United States Supreme Court (October 2015). He has also published in other highly regarded journals, such as Ageing and Society, Applied Geography, Disability and Rehabilitation, Journal of Aging and Health, and Women’s Health Issues. Sharma is a former recipient of the Carolina Population Center Fellowship with training grants from the National Institute on Aging and the National Institute for Child Health and Human Development. He also received the Future Faculty Fellowship and Weiss Urban Livability Fellowship at the University of North Carolina at Chapel Hill, where he completed his PhD. He has master degrees in mathematics from Loyola University Chicago and economics from DePaul University.
