Our Team
Dr. Beth Cudney
Dr. Beth Cudney, President of Cudney Consulting Group, brings a wealth of expertise and experience in data analytics and quality management. Her illustrious career began in 1996 within the corporate sector, serving as a Six Sigma Black Belt and Senior Manufacturing Engineer for Dana Corporation and Danaher-Jacobs Vehicle Systems. Dr. Cudney's dedication to excellence led her to pursue advanced education, earning an MBA and MEng in Mechanical Engineering from the University of Hartford.
Transitioning to academia in 2000, Dr. Cudney began her tenure as an adjunct professor at her alma mater, teaching Six Sigma. Her passion for education and research flourished, culminating in the completion of her doctorate in engineering management from the University of Missouri–Rolla in 2006. Dr. Cudney's academic journey saw her rise to prominence, assuming roles such as associate chair of graduate studies and associate professor of engineering management and systems engineering.
A prolific scholar and author, Dr. Cudney's contributions to the field are unparalleled. With numerous books, anthology chapters, journal articles, and conference presentations to her name, she is widely recognized for her groundbreaking work in quality management. Her accolades include prestigious awards such as the Crosby Medal from ASQ and the Walter E. Masing Book Prize from the International Academy for Quality.
Certified as a Lean Six Sigma Master Black Belt, Dr. Cudney's commitment to excellence is further demonstrated through her eight ASQ certifications, including Certified Quality Engineer and Manager of Quality/Operational Excellence. Currently serving as a Professor of Data Analytics and Program Coordinator at Maryville University, Dr. Cudney continues to inspire and empower individuals and organizations alike to achieve operational excellence and sustainable success.
Brian Cudney, MBA, CSSBB
Brian Cudney, a distinguished Partner at Cudney Consulting Group, is responsible for spearheading scientific and regulatory consulting activities associated with pharmaceutical product development, alongside overseeing global regulatory affairs. With over two decades of hands-on experience in the pharmaceutical industry, Brian's expertise spans research and development, technical transfer, scale-up, validation, and regulatory affairs for a diverse range of dosage forms and product types.
Throughout his career, Brian has played pivotal roles in managing drug development teams, preparing investigational and marketing applications, and handling post-approval regulatory submissions. His keen insight and strategic acumen have been instrumental in crafting global regulatory strategies, ensuring compliance, and implementing quality by design strategies to optimize product development processes.
Brian's extensive experience encompasses various facets of pharmaceutical operations, including design optimization, contract manufacturing, and formulation development. His dedication to excellence is exemplified by his proactive approach to meeting regulatory requirements and fostering collaborative partnerships to drive innovation.
In addition to his professional achievements, Brian's collaborative spirit and enthusiasm for advancing drug development are evident in his interactions with colleagues and stakeholders.
Richard Unger, MS
Richard Unger is a seasoned pharmaceutical professional with 25 years of experience supporting some of the world's leading pharmaceutical companies. He specializes in various critical areas, including clinical research, regulatory affairs, labeling, and quality assurance.
Throughout his career, Richard has played a vital role in the development and submission of Investigational New Drug (IND) and New Drug Application (NDA) filings, managing all aspects from strategy to documentation for Modules 1 through 5. His expertise in regulatory affairs spans the U.S., EU, Latin America, and international markets, allowing him to navigate complex regulatory landscapes effectively.
Richard's work in clinical research has involved overseeing clinical trials and ensuring compliance with regulatory standards, which is essential for the successful development of new therapies. Additionally, he has significant experience in drug labeling, ensuring that product information is clear, accurate, and compliant with regulations.
In quality assurance, Richard has implemented rigorous quality management systems that uphold the highest standards for pharmaceutical products. His proactive approach to quality and compliance has been instrumental in fostering innovation and maintaining public trust in pharmaceutical products.
Richard earned a Master of Science degree in Regulatory & Quality Compliance from Purdue University's School of Industrial Pharmacy, which has provided him with a solid foundation in the principles of regulatory science and quality management. His combination of extensive experience and academic knowledge makes him a valuable asset in the pharmaceutical industry, where he is committed to advancing drug development and ensuring patient safety.