Q. Please tell us about yourself. What brought you to your current position?
I began my career as a cellular and molecular biologist, studying brain cancer and teaching biology and biotechnology at the university level. I truly love teaching adults and believe that my company’s training program is one of the best in the industry. I also studied U.S. law, and have a diploma in International and French Law to better interpret global GMPs.
Later, I used my scientific and legal background as a drug investigator at the FDA to inspect manufacturers and contract testing laboratories. I also served as the director of Quality Systems & Compliance at Merck. Currently, I teach regulatory courses at Morehouse School of Medicine and am the CEO and principal consultant at Polymath Regulatory Consultants, LLC.
Q. What is your favorite part of the work you’ve done in this field?
I got into manufacturing quality and compliance by accident. After being a professor for several years, I decided to apply to the FDA as a drug investigator. I quickly fell in love with manufacturing. The best parts of being a GMP and quality consultant are learning new technologies, manufacturing processes, and laboratory methods and, above all, helping my clients provide the best products and services to their customers!
Q. What is your talk about?
I will be discussing FDA 483 and Warning Letter trends as they relate to laboratory testing. I hope that by focusing on lab-specific issues, contract laboratories will be better equipped for health authority inspections.
Q. Why do you think it’s important to discuss this topic with our audience?
Understanding the current trends is a necessity for testing laboratories given that all manufacturing requires some type of testing for product release. Companies should be aware of hot topics and the FDA’s areas of focus to remain ever-ready for inspections and provide the highest level of service to their customers.
Dr. Constance Y. Fears is the CEO & principal consultant of Polymath Regulatory Consultants, LLC. Constance brings two decades of technical, legal, and life sciences/pharmaceutical manufacturing experience to Polymath. She holds a PhD in cellular and molecular biology, a Juris Doctor degree, and a graduate diploma in International and French Law. She is an avid supporter of environmental conservation, human rights, and STEM education in underrepresented groups. Constance has held various positions including, molecular biology post-doctoral research fellow, tenure-track university professor, US FDA-certified drug investigator, and director of Quality Systems & Compliance at one of the world’s largest pharmaceutical companies. Combining formal education and professional experience, she offers broad technical and regulatory expertise when solving complex quality and compliance matters.
Register today for free to attend Constance’s and other insightful webinars at the 2025 Laboratory Quality and Compliance Week!
