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Regulatory Compliance

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.

Anushree Bhatnagar

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Currently teaching:
Drug and Biologics Regulations

Anushree Bhatnagar is currently a senior manager of product quality in the Global Quality division at Baxter Healthcare in Deerfield. Prior to Baxter, Bhatnagar worked at Hospira as a product quality lead for drugs and biologics. She has extensive experience in leading new product development activities for biosurgical devices, biologics/biosimilars, and pharmaceuticals. Prior to working in the pharmaceutical and device world, Bhatnagar worked on FDA-regulated and investigator-initiated research as a postdoctoral fellow ant Cleveland Clinic, dissecting the molecular pathway of chronic disease progression to discover novel targets for therapeutic intervention. She was an NIH-NRSA scholar and recipient of several honors for scientific excellence and communication. Bhatnagar holds a PhD in biochemistry from Case Western University, Cleveland Ohio.

Stanley Bouma

Stanley Bouma

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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.

Paula Carney

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Paula Carney is assistant provost and director of graduate programs at Chicago State University. She has 20 years of experience in FDA regulated and investigator initiated research. In addition, she has teaching experience at Wayne State University and at the University of Tennessee where she taught research methods, biostatistics and public health. Carney also has experience designing research training materials for pharmaceutical companies and public health departments. Prior to her current position, she managed online compliance training for the U.S. acute care market for Thomson. In addition to her clinical background as a registered dietitian, she also holds the Healthcare Research Compliance Certification credential. Carney holds an MS from the University of Wisconsin-Madison and a PHD in instructional technology with a minor in evaluation research and statistics from Wayne State University in Detroit.

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.

Mark Clare

Mark Clare

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Currently teaching:
Foundations of Leadership

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.

Eytan Dallal is a senior healthcare IT executive with over 20 years of experience in the private and public sectors, helping organizations think beyond simply using technology as a tool, and leading implementations of technology as a strategic business driver. As a former CIO at the State of Illinois' Health and Human Services Division and currently as the CIO of the Blue Cross Blue Shield of Illinois Medicaid State Plan, Eytan understands the complex nature of managing and security healthcare data across business silos and the challenges from a legal, compliance, security, privacy, and interoperability perspective. He holds a Master's in Health Informatics from the College of Applied Health Sciences at the University of Illinois at Chicago, a Bachelor’s in Business Management from NEIU, and several industry certifications including HCISPP and HIPAA. Dallal has previously developed and led technology courses for Touro College and University.

Anne Sullivan Daly serves as the chief compliance and integrity officer at the Ann & Robert H. Lurie Children’s Hospital of Chicago. Prior to Lurie Children's, Daly worked as the senior director in Banner Health’s Ethics and Compliance Department and at Sutter Health as the regional compliance officer. Prior to working in compliance, Daly worked as a health care attorney at two large law firms in Washington, DC, where she specialized in health care regulatory issues, and prior to the practice of law, worked as a registered nurse in a variety of settings in the United States and overseas. Daly earned her Juris Doctor from the Catholic University of America, Columbus School of Law, in Washington, D.C., where she was associate editor of the Journal of Contemporary Health Law and Policy and studied European Law at the Jagiellonian University in Krakow, Poland. Daly holds certifications in health care compliance (CHC), research compliance (CHRC), privacy (CHPC), and compliance and ethics (CCEP). She is also a member of the Maryland Bar, District of Columbia Bar, and United States District Court for the District of Maryland Bar and holds a Registered Nurse license in California.

Abigail Davis possesses over 20 years in the industry including experience ranging from large, publicly- traded, highly-regulated companies to small, privately-owned, less-regulated companies. After graduating from University of Wisconsin – Madison in the 1990s, Davis worked in small contract labs conducting food testing and sterility testing on consumer products and medical devices. After those experiences, she joined Abbott Laboratories in northern Illinois. During her time at Abbott, Davis worked in multiple divisions, including the Diagnostics and Molecular divisions and she also worked in Corporate Quality and Regulatory. During her time with Abbott, she worked in a number of different functions and performed a large array of activities including manufacturing IVD products, QC testing products, qualifying manufacturing equipment. She also executed process validations, conducted internal and supplier audits, and hosted FDA inspections. Daivs currently works at Promega Corporation as a senior manager overseeing the quality system. She holds a master’s degree in Biotechnology from the University of Wisconsin – Madison.

Valerie Followell

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Valerie Followell has more than 20years of experience in regulated industries. She currently provides consulting services through Followell Compliance Consultants, LLC. Prior to starting her own firm she was the director of regulatory affairs for Medline Industries. Over her career she has managed regulatory affairs teams for Teleflex Medical and Hospira as well as holding both quality and regulatory positions in drugs, biologics and devices at Baxter Healthcare. Followell received her MBA from Webster University, St. Louis.

Patricia Gregory has over 30 years of experience executing successful healthcare billing and compliance programs. She currently works at the Shirley Ryan AbilityLab (SRAlab) as the compliance revenue integrity officer, identifying compliance billing abnormalities, remediating risks, ensuring compliance, and identifying growth and revenue opportunities. She has previously served as the compliance program manager for a three hospital healthcare system. While with Walgreens, Co., Gregory performed risk analysis, revenue verification and integration planning for acquired businesses. She also instituted and chaired the first Medicare Task Force committee focused on validating adherence to governmental regulations. She received her MS in computer science (human computer interaction) from DePaul University, Chicago, and is HCCA certified in research compliance, healthcare privacy, and health care compliance.

Sheri Jacobsen is the director of development training at AbbVie. She has over 20 years of experience in the pharmaceutical research industry, having held multiple roles across all levels of industry including the areas of site investigation, clinical research organization and biopharmaceutical sponsorship. Currently, Jacobsen is responsible for ensuring that all functions supporting global pharmaceutical development at AbbVie have the training needed to execute clinical programs while ensuring regulatory compliance. She has an MA in clinical psychology with a concentration in neuropsychology from the Illinois School of Professional Psychology and a nursing degree.

Tina Krenc is director of R&D quality assurance in Abbott Laboratories’ molecular division. Since joining Abbott in 1982, she has had experience in research and development, clinical research, operations support and quality assurance. She was the project coordinator for developing and implementing a worldwide design-control quality system for the Abbott diagnostics division. Krenc is also involved in risk management outside Abbott. She serves as a US Technical Advisory Group delegate to an International Organization for Standardization technical committee; she has presented about risk management to the FDA and at international meetings; and she is an instructor for the Association for the Advancement of Medical Instrumentation risk management class. Krenc received a master of science degree in product development from Northwestern’s Robert R. McCormick School of Engineering and Applied Science.

Robert Lechton

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Currently teaching:
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.

Teresa Meiszberg has over 33 years of healthcare industry experience, including 24 years at Abbott Laboratories in various quality leadership roles. Most recently, she managed the Abbott Nonconformance and CAPA (Corrective Action/Preventive Action) Programs in the Corporate Quality and Regulatory Division, supporting device, nutritional and pharmaceutical businesses. In this role, Meiszberg redesigned the quality system to include the regulatory requirements for the global boundaries of the company, developed and delivered quality system training, and regularly guided business audit responses and process improvement initiatives. Prior to Abbott, she worked in hospital and clinical laboratories. Meiszberg has a Master of Science in Engineering and Technology Management from Oklahoma State University and a Certificate of Graduate Study in Medical Device Leadership for Patient Health and Business Success from Xavier. Her additional certifications include American Society of Clinical Pathologists (ASCP) Board of Registry, Medical Technologist; and American Society of Quality (ASQ) Certifications, including Certified Quality Manager/Operational Excellence, Certified Quality Engineer, and Certified Quality Auditor.

William Mickelson

William Mickelson

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Currently teaching:
Statistical Analysis

William T. Mickelson is an applied statistician with more than 25 years of statistical consulting, measurement, evaluation and survey research experience in both academia and industry. Mickelson was on the faculties of the University of Idaho, the University of Nebraska–Lincoln, and the University of Wisconsin–Whitewater. He has also worked with the RAND Corporation as a policy analyst and with Chamberlain Research Consultants of Madison, Wisconsin, as a senior consultant and division director. Mickelson has taught across the entire spectrum of research and statistical topics, including applied statistics, probability, modern robust and nonparametric methods, multivariate methods, regression, experimental design and ANOVA and mathematical and statistical modeling. His current research interests include the robustness of commonly used statistical tests and predictive models, the use of modern resampling and nonparametric statistical methods and the teaching and learning of statistical reasoning, thinking and literacy. Mickelson received his PhD in educational psychology in quantitative methods from the University of Wisconsin–Madison and a master’s degree in statistics from Michigan State University.

Suzen Moeller

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Currently teaching:
Applied Research and Writing

Suzen M. Moeller is on the faculty of the School of Nursing and Health Sciences at North Park University in Chicago. She is the founder of Eating Joyfully, Inc and co-founder of Compassion Catalysts, LLC which offer workshops and other educational programs on the role of spiritual wellbeing in health and healthcare. Moeller previously worked as a senior scientist at the American Medical Association (AMA) on scientific and public policy issues related to diet and nutrition, and helped develop and evaluate educational resources for healthcare professionals and patients. While much of her academic research has focused on the role of diet in age-related eye diseases, some of her earliest academic work involved nutrition interventions in mothers and infants in sub-Saharan Africa. Moeller received her PhD in nutritional epidemiology and MS in human nutrition science from the Friedman School of Nutrition Science and Policy at Tufts University in Boston and completed her post-doctoral training at the University of Wisconsin-Madison.

Andrew Naidech

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Russell Roberson

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Currently teaching:
Foundations of Leadership

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.

Kimberly Rusk is the president of Optimyze Research, LLC. She offers a variety of consultative services to academic and community based clinical research organizations, as well as providing administrative support for the rigorous processes involved in conducting clinical research to both industry sponsors and investigators. Rusk has been involved in all aspects of clinical research for several decades, from delivering clinical care to research participants to developing comprehensive training programs and authoring and implementing quality assurance standards and procedures. She previously was the director of the Office of Clinical Research, at the University of Chicago. She received her BSN from the University of Illinois at Chicago and an MSHS from George Washington University.

Jeffrey Sartain

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Currently teaching:
Practical Quality Management

Jeffrey Sartain is a senior consultant providing quality system, regulatory compliance and general business subject matter expertise and project management services to health care product manufacturers. He has more than 30 years of experience within the medical device, diagnostics, pharmaceutical and food sectors, encompassing roles in quality and regulatory, engineering, and manufacturing, including international regulations and standards. Sartain's areas of expertise include compliance, quality system development and remediation, GxP, supplier/3rd party contract manufacturing controls, CAPA, complaint handling, and product development/transfer. Sartain earned a master's degree in manufacturing engineering from Northwestern University and has earned prior certifications as Quality Manager (ASQ), Lead Auditor (Stat-A-Matrix), Quality Systems/GMP (AAMI), and in Quality Engineering (ASQ).

Sunita Upadhyaya

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Currently teaching:
Medical Device Regulations


Manu Vora has almost 50 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 articles and 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.

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