EPIC 135 SUSTAINABILITY LIVING LEARNING (1 credit)This course allows residents of the Sustainability Living Learning Community to explore a variety of sustainability topics. Course activities include discussions with faculty and staff about campus sustainability topics such as energy, water, waste and food. Group discussions and activities address personal sustainability habits and choices.
EPIC 242 COMMUNITY HEALTH AND MEDICINE (1 credit)Students will learn medical, technical and clinical competencies from a variety of health care professionals with the goal of becoming a trained Health Coach. This course serves as a required pre-program orientation course for students participating in the partnered Center for Global Health and Reid Hospital Community Medicine Program.
EPIC 250 QUALITY REGULATIONS IN LIFE SCIENCE (3 credits)This course, as part of the curriculum developed by Pathway for Patient Health, will provide 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 pharmaceutical, medical device, biotech, animal health and consumer goods 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.
EPIC 350 PRODUCT DEVELOPMENT, SPECIFICATIONS, PROCESSES AND VALIDATION (3 credits)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), and 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. Prerequisite: EPIC 250.
EPIC 351 RISK AND FAILURE ANALYSIS (2 credits)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). Prerequisite: EPIC 250.