Regulatory Compliance

Faculty

Carol Beirne

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.

Currently teaching:Quality Systems for Regulatory Compliance
Capstone Project

Stanley Bouma

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.

Currently teaching:Risk and Decision Management

Michaelle Carling

Shelly Carling is a site compliance officer for Advocate Health Systems. She has over 20 years of experience in healthcare, mainly in acute care non-profit hospitals but also within the medical device industry. Carling has an MBA from Loyola University Chicago and a Juris Doctorate from Loyola’s School of Law, where she also teaches.

Currently teaching:Healthcare Billing Models and Systems

Kelly Carroll

Kelly Carroll has more than 20 years of experience teaching graduate and undergraduate courses in psychology and education at institutions including the University of Arkansas and University of Chicago and was a professor of experimental psychology at Mercer University and Berry College. She has designed education and training materials for Northwestern’s clinical research community and assisted study teams in conducting safe and effective studies. She also has many years of experience in the regulatory and compliance arena and was an institutional review board manager. Carroll received her PhD in experimental psychology from the University of Arkansas.

Currently teaching:Clinical Research Design and Methodology
Applied Research and Writing
Essentials of Initiating Clinical Research

Mark Clare

Mark Clare, founder of New Value Streams Consulting, has more than 20 years of experience in knowledge management, strategic change and informatics with Fortune 200 companies, including 3M and Allstate. His previous executive positions include vice president of knowledge and informatics management at Parkview Health, a nine-hospital system in northeast Indiana. Clare is author of many publications, including the book Knowledge Assets and a series of articles in KM Review on “Solving the Knowledge-Value Equation.” He holds a patent in artificial intelligence and has several more patents pending. Clare has an MS in physics, an MA in analytic philosophy and a Six Sigma Black Belt.

Currently teaching:Foundations of Leadership

John Cooper

John Cooper is a managing partner of Milestone Partners. His 30 years in business include line management, internal and external consulting, effectiveness training, strategic planning, organization design, change management, and executive coaching. He has served dozens of clients in the Chicago area, including Fortune 100 companies and nonprofit organizations. Cooper is former president of the Organizational Development Network of Chicago, has served on the board of directors of the Human Resource Association of Chicago, and has been certified in various development tools, including Center for Creative Leadership Benchmarks 360 and Hogan Leadership Assessment Series. Cooper has an MS in organizational development from Aurora University and advanced coaching training through the International Gestalt Coaching Program.

Currently teaching:Foundations of Leadership

Leyla Erkan

Leyla Erkan is the corporate compliance and privacy officer at the Rehabilitation Institute of Chicago Hospital, where she oversees all compliance related matters, including research compliance, conflict of interest and governmental audits; maintains the hospital’s privacy office; and administers enterprise risk management. She previously was the RIC’s interim executive director of research administration and corporate compliance director at Children’s Memorial Hospital. Erkan received a master’s of jurisprudence degree from Loyola University Chicago School of Law.

Currently teaching:Healthcare Compliance Programs

Valerie Followell

Valerie Followell has more than 15 years of experience in regulated industries. She is the associate director of regulatory affairs for Medline Industries, and prior to that managed global regulatory affairs for Teleflex Medical. She has held both quality and regulatory positions in drugs, biologics and devices at Baxter Healthcare. Followell received her MBA from Webster University, St. Louis.

Currently teaching:Medical Device Regulations

Robert Lechton

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.

Currently teaching:Risk and Decision Management

William Lester

William Lester is the MPPA faculty director and a scholar of political science and public administration. His research interests include leadership and ethics, public administration, disaster response, organizational theory, public personnel, and American politics. He has published in Public Administration Review and The Public Manager, among other journals, and is on the editorial board of Public Voices. He has a book forthcoming in the American Society for Public Administration series entitled Transformation and Leadership in Disaster Response. Lester was named a 1999 Civitas Scholar and was also a 2009 participant in Minnowbrook III. Recently, Lester was named a Fulbright scholar, teaching and researching in Moscow. He received his MPA and PhD from Texas Tech University with specializations in public administration, American politics, and political theory.

Currently teaching:Foundations of Leadership

Pamela Mason

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.

Currently teaching:Quality Systems for Regulatory Compliance
Practical Quality Management
Drug and Biologics Regulations

Patricia McNally

Patricia McNally is assistant dean in the medical education department at Loyola University Chicago Stritch School of Medicine. She is a Harvard Macy Scholar with 20 years of experience working with adult learners in a variety of areas, including management, leadership, organizational development, human resource development and medical education. McNally draws from corporate, higher education administration and instructional experience to bring her learners a multifaceted view of organizations and organizational learning. McNally received her doctorate in education from National-Louis University.

Currently teaching:Foundations of Leadership

Tracey Rae

Tracey Rae is Principal Scientist in research and development for Abbott Laboratories’ diagnostics division. His responsibilities include test method development and analysis of biological reagents for immunoassay diagnostic products in research phases. Rae previously served three years within the operations area of Abbott’s diagnostics division, where he was responsible for on-market product quality support from incoming reagents through manufacturing and testing processes. He received his doctorate in chemistry from the University of Iowa, followed by postdoctoral NIH Fellowship research training at Northwestern.

Currently teaching:Applied Quality and Regulatory Practices

Russell Roberson

Russell Roberson is vice president of quality and regulatory affairs for a global medical company, assuring that products and services are designed, manufactured, distributed, and serviced properly. He has responsibility for an extensive portfolio of healthcare software products in both medical (pharmacy, imaging, electronic medical records, and prescription management products) and nonmedical (financial and data-privacy products) device areas affected by global regulation. Roberson is a frequent speaker at global conferences on such topics as software design processes, regulatory affairs, and quality management systems. A licensed professional engineer, he holds professional certifications in engineering, auditing, and management; is active in several professional societies; and sits on his college fraternity’s national board of trustees. Among his publications are two books on leadership and cancer management. Roberson has a doctorate in business administration and management, an MBA degree, and a MS in mechanical engineering.

Currently teaching:Foundations of Leadership

Manu Vora

Manu Vora has more than 40 years of leadership experience as a specialist in quality-enhancement consulting, with emphasis on total quality management, the Baldrige Performance Excellence Program, and ISO 9000 certification. Vora has worked with AT&T Bell Laboratories for more than 17 years. He is currently the chairman and president of Business Excellence, Inc. Vora is a past vice president of the American Society for Quality (ASQ), an ASQ Fellow, and an ASQ-certified quality engineer. He has been recognized by ASQ with 5 Medals. He has published more than 60 articles and made over 610 presentations on business excellence and quality management globally. He has been appointed as a Fulbright Specialist by the U. S. Department of State's Bureau of Educational & Cultural Affairs. Vora has a PhD and MS in chemical engineering and an MBA in marketing management.

Currently teaching:Quality Assurance Project Management

Karriem Watson

Karriem Watson is a research manager at the Center for Interdisciplinary Inquiry and Innovation in Sexual and Reproductive Health at the University of Chicago. He has more than 13 years of experience in clinical research, working as a clinical research associate, project manager and coordinator in both academic and industry settings. His research focuses on community engagement in clinical trials and capacity building of community partners and addresses issues about enrollment of diverse populations in clinical trials. He is cofounder and copresident of AcaMED Clinical Research Associates, where he focuses on training investigators and clinical research staff on successful protocol design, execution and recruitment. Watson completed his medical doctorate at St. Luke School of Medicine in Monrovia, Liberia, an MS in basic medical sciences at Wayne State University College of Medicine and an MPH at the University of Illinois at Chicago.

Currently teaching:Applied Research and Writing
Capstone Project

Elizabeth Zurek

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.

Currently teaching:Healthcare Regulatory Environment