Regulatory Compliance Faculty
Carol Beirne
Faculty Director
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Carol Beirne has over 27 years of experience at Abbott Laboratories in various 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 been extensively involved in process improvements throughout her career. She led a quality training staff in the Global Pharmaceutical Research and Development organization with German and US employees. She has served in multiple roles in CAPA investigations.
Eytan Dallal
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Eytan Dallal is a senior healthcare IT executive with over 25 years of experience in the private and public sectors. His work helps organizations think beyond using technology as a tool and leading technology implementations as a strategic business driver. As a former CIO in healthcare in the public and private sectors, he 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.
Dallal has served as a keynote speaker and panelist in many seminars, recognized for his in-depth knowledge of technology, strategy, and business. 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 is an active member of AHIMA, HIMSS, and (ISC)2. He serves on the board of a community non-profit organization supporting education.
Abigail Davis
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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 the University of Wisconsin – Madison in the 1990s, Davis worked in small contract labs conducting food and sterility testing on consumer products and medical devices. After those experiences, she joined Abbott Laboratories in northern Illinois. At Abbott, Davis worked in multiple divisions, including the Diagnostics and Molecular divisions and Corporate Quality and Regulatory. During her time with Abbott, Davis worked in many different functions, including manufacturing IVD products, QC testing products, and qualifying manufacturing equipment. She also executed process validations, conducted internal and supplier audits, and hosted FDA inspections. Davis 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.
Patricia Gregory
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Patricia Gregory has over 30 years of experience assisting healthcare organizations in collecting revenue and, more importantly, keeping it. She is experienced at executing successful healthcare billing and compliance programs in a broad range of health care settings ranging from a Fortune 20 corporation to a physician-owned infusion pharmacy to a nonprofit health system. Gregory's skill set includes identifying billing abnormalities, remediating risks, building workforce awareness and knowledge to ensure payer compliance, and uncovering growth and revenue opportunities. She spent nearly a decade with Walgreens Co., leading revenue verification, integrating acquired businesses, and performing validation audits to monitor adherence to governmental regulations. Gregory has previously served as the Compliance Program Manager for Edward-Elmhurst Health, a three-hospital healthcare system in Chicago's western suburbs. She currently serves as the Chief Compliance and Privacy Officer for the Shirley Ryan Abilitylab (SRAlab). Gregory holds certifications in Research Compliance (CRC), Healthcare Privacy Compliance (HCPC) and Healthcare Compliance (CHC). Gregory received her BA in Organizational Behavior from Benedictine University, Lisle, IL, and her MS in Human Computer Interaction from DePaul University, Chicago, IL.
Sheri Jacobsen
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Sheri Jacobsen has over 20 years of experience in the pharmaceutical research industry, having held multiple roles across all industry levels, including site investigation, clinical research organization, and biopharmaceutical sponsorship. Currently, Jacobsen ensures 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.
Robert Lechton
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Robert Lechton is a senior quality manager at Baxter Healthcare. He is responsible for quality compliance for medical products, including design control, risk management, and life cycle management. Lechton has been involved in product development, from early concept to product launch and throughout fielded products. He previously was the quality manager for Bosch Rexroth’s Electric Drives and Controls division. Lechton received an MS in Engineering from the University of Maryland focusing on reliability engineering and risk management and a BS in Electrical Engineering from Bradley University.
Nick McWilliams MS, PMP
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Nick McWilliams has been in the pharmaceutical research industry since 2005. He has held roles within data management, clinical operations, and project management. His current position is Senior Clinical Project Manager at IQVIA Biotech, working on oncology studies with emerging biotech and non-profit industry sponsors. He graduated from the MSRC program in 2015 and is excited to bring his experience back to Northwestern to share with students.
Teresa Meiszberg
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teresa.meiszberg@northwestern.edu
Teresa Meiszberg has over 33 years of healthcare industry experience, including 24 years at Abbott Laboratories in various quality leadership roles. She recently 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 the 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.
Jeffrey Sartain
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jeffrey.sartain@northwestern.edu
Jeffrey Sartain is a senior consultant providing quality systems, regulatory compliance, general business subject matter expertise, and project management services to health care product manufacturers. He has over 30 years of experience in 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/third 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).
Dr. Manu K. Vora
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Dr. Manu Vora is Chairman and President of Business Excellence, Inc., a global quality management consulting service firm. He has over 46 years of leadership experience guiding Fortune 500 companies with the Baldrige Performance Excellence Award assessment. He served as a Chief Judge at the Illinois Team Excellence Award Program from 1993-1999 and was a Senior Examiner of the Asia Pacific Global Performance Excellence Award Program from 2004-1017. Vora is a Past VP from the American Society for Quality (ASQ) National Board of Directors and is an ASQ Fellow.
He holds an MBA in Marketing Management from the Keller Graduate School of Management in Chicago, M.S. & Ph.D. in Chemical Engineering from Illinois Institute of Technology in Chicago, and B. Tech. (Honours) in Chemical Engineering from the IIT (BHU), Varanasi in India. He has over 1.100 presentations around the world. In 2013, he gave two TEDx talks. He has published over 70 scholarly articles. In 2016, he delivered "Project Management for Organizational Excellence," a GIAN course approved by MHRD-Government of India. In 2016, he was appointed as a Fulbright Specialist by the U.S. Department of State. In March 2018, he completed his Fulbright Specialist Project at IIT (BHU), Varanasi. He has taught "Quality Assurance Project Management" course at Northwestern University's School of Professional Studies since 2008. He has received 56 awards/honors for his outstanding professional service.
For over 51 years, Dr. Vora has dedicated his life to community service. In 1989, he established the Blind Foundation for India (BFI) to serve over 15 million visually impaired people in India. The BFI team has raised over $5 million to support over one million adults and one million children in India for their eyesight check-ups. Since 1970, Dr. Vora has raised over $12 million for various charitable and professional causes. He has received 35 awards/honors for his life-long community service, including the U.S. President's Volunteer Service Award.
leave emptyLauren Wall, MS
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Lauren Wall has over 15 years of experience in Hematology/Oncology clinical research operations spanning industry and academic healthcare. Her primary responsibilities include planning, organizing, directing, and overseeing daily operations for over 300+ therapeutic clinical trials within a section that accrues approximately 1200+ patients a year to interventional trials.
Lauren assists in developing and executing strategic and operational plans (including fully integrated network sites) for clinical research, including new business practices and Standard Operating Procedures (SOPs). Lauren holds an MSc degree in Clinical Research Administration from George Washington University. In addition to her role mentioned above, Lauren is an appointed Institutional Review Board (IRB) and Clinical Trial Scientific Review (CTRC) committee member at the University of Chicago. Prior to taking her role in the academic setting, Lauren worked at an Oncology CRO, Theradex, where she gained experience in clinical trial monitoring, auditing, and project management. Lauren traveled to several NCI-designated cancer centers to conduct site visit audits. Lauren has a strong passion for teaching and mentoring others about the exciting career opportunities in clinical research.
Colleen Watson
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Colleen Watson, MS is currently a Senior Director of Regulatory Affairs at Thermo Fisher Scientific. She is experienced working with both medical devices and in vitro diagnostics. Colleen has overseen, product development regulatory, international regulatory affairs teams globally, design assurance, and product material compliance. Previously, she has worked in Regulatory Affairs in infectious disease, oncology, and respiratory at Abbott Molecular, CareFusion/BD, and Vyaire Medical. Colleen is currently a doctoral candidate in Regulatory Affairs at the University of Southern California. She received her B.S in biochemistry from the University of Wisconsin-Madison. After graduating, she worked at the bench level doing drug chemistry and forensic toxicology, writing methods, and testifying in court. After earning a M.S. in Biotechnology, also from Madison, focused on integrating science, law, and business – Colleen fell in love with the Regulatory Affairs field. She enjoys the challenge of building an effective team, bringing new products to the market, and seeing the direct benefit to patients. Colleen has a large blended family with teenagers and two dogs; in her spare time she enjoys dog walks, traveling, reading novels, and browsing art shops.