Regulatory Compliance

Faculty

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:Practical Quality Management

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

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