Quality Science

Programs

Courses

QSC 250: Global Regulatory & Legal Requirements of Quality

Credits 3
This course, as part of the Quality Science Education curriculum developed by Pathway for Patient Health, will give students an understanding of the role of regulators with an overview of regulations as stated in the U.S. Code of Federal Regulations (CFR), EudraLex Directives and Annexes, and Emerging Market regulations for the life science industries. The faculty will demonstrate the relationship between regulatory requirements and legal accountability while introducing fundamental concepts in the regulations related to clinical trial development, management, ethics, data integrity, data security, privacy, change control, and validation. Topics such as the role of guidance documents and industry standards will be reviewed, and case studies utilized to support the program. The “why” of the regulations will support the student's ability to enter the life science industry with an understanding of how to optimize patient health and business success by mobilizing enterprise-wide quality effectiveness through innovative systems and critical thinking grounded in science, data, stakeholder awareness and regulatory intelligence. While the course content, developed by Pathway for Patient Health, will be provided online, regular meetings with the instructor are expected.

QSC 350: Product Development and Validation

Credits 3

In this course, students will be exposed to the major design processes that are critical to life science product, process and specification development. Topics to be covered include: cradle to grave 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 plan, process characterization, installation qualification, operational qualification, measurement system analysis, repeatability and reproducibility (data collection / analysis), performance qualification/ validation. In a world of innovative technology, it is critical that the students gain an understanding of computer system and software validation to ensure the quality of data generation, data storage, and digital processes used in manufacturing and products with digital components using technical and practical aspects expected in the regulated life science industries. While the course content, developed by Pathway for Patient Health, will be provided online, regular meetings with the instructor are expected.

QSC 351: Risk & Failure Analysis

Credits 3
This course 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, such as FMEA, Fault Tree, and 5 Why's, 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). While the course content, developed by Pathway for Patient Health, will be provided online, regular meetings with the instructor are expected.