Manhattan University today announced the creation of a new Quality Science minor for the 2025 Fall Semester that will expand opportunities for students interested in the pharmaceutical industry. There is a great need in pharmaceutical and drug device industries to ensure that the medicines, dietary supplements, devices, and other products meet quality and safety standards to build patient trust and improve global health. Although risk and failure analysis is currently taught at many universities, the Manhattan University minor will dive into the nuances of the life science industries related to the specific regulations that apply to consumer health products. Through the use of historical risk analysis techniques, students will be able to analyze a holistic set of data (in-production, across product lines, across equipment, human variability, on-market, on-stability, validation studies, change control, etc.) that will lead to scientifically justified investigations supported by evidence, and the identification of effective corrective and preventative actions (CAPA).
Said Marcy Kelly, Ph.D., Dean of the Kakos School of Arts and Sciences at the University, “As a scientist myself, I know there is great value in offering our students a Quality Science minor, particularly to business, science/mathematics, or engineering majors. Students who complete this minor will receive a Certified Quality Science Professional (CQSP) micro-credential and will benefit from our collaboration with Pathways for Patient Health. Pathways will provide students enrolled in the minor with opportunities for mentoring and access to its hiring platform for internships and jobs.”
Topics to be covered in the Quality Science minor include: complete life cycle product and process development, prototype builds, scalability, design of experiments, variability, control, specification development, and validation methodology. Instructors will explore how rigorous human factor engineering studies and clinical trials provide essential inputs into the product development process. The students will be introduced to concepts such as gap analysis, risk assessment, master planning, process characterization, installation qualification, operational qualification, measurement system analysis, repeatability and reproducibility (data collection / analysis), and performance qualification/validation.
For additional information on the Quality Science minor, please contact Dr. Kelly at mkelly16@manhattan.edu.