• REST 4630: Continuous Quality Improvement

  1.00 - 2.00 Credits

  Weber State University

  
  The continuous quality improvement project enhances an understanding of how to construct and conduct a quality improvement (quality assurance) project in the workplace. Enrollment by permission only.
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• REST 4800: Independent Projects

  1.00 - 6.00 Credits

  Weber State University

  
  Student designed, instructor approved projects which will further develop cognitive or psychomotor skills for the baccalaureate level respiratory care practitioner. Projects must meet departmental and professional goals and standards and must have instructor approval prior to beginning project. Enrollment by permission only.
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• REST 4830: Directed Readings

  1.00 - 3.00 Credits

  Weber State University

  
  Student designed, instructor approved readings which will further develop professional knowledge or understanding for the baccalaureate level respiratory care practitioner. Readings must meet departmental and professional goals and standards and must have instructor approval prior to b beginning. Enrollment by permission only.
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• REST 4850: Study Abroad

  1.00 - 6.00 Credits

  Weber State University

  
  The purpose of this course is to provide opportunities for students in health professions to experience a study abroad program that is designed to explore healthcare, culture, and clinical experience. May be repeated 5 times with a maximum of 6 credit hours.
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• REST 4990: Senior Seminar

  2.00 Credits

  Weber State University

  
  Moderated discussion and/or laboratory experiences relating to current events in healthcare, legislative, credentialing, and licensing issues as well as emergent technologies and advanced educational opportunities in the field.
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• RGAF 6000: Intro to Regulatory Affairs

  3.00 Credits

  Weber State University

  
  This course is designed to present an introduction to the regulations, documents and processes necessary for FDA approval of new medical products. The course covers an overview of critical scientific, technical, engineering design, manufacturing, and operational drivers for national and global regulatory compliance. This course also discusses the historical context in which the FDA evolved, its structure and relationship with other US regulatory agencies. The course will provide an overview of market clearance pathways for various medical products and devices that ensure the development and delivery of safe and effective healthcare products to consumers.
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• RGAF 6100: Biostatistics Applied Research

  3.00 Credits

  Weber State University

  
  Advanced biostatistics as applied to research. The concepts of populations, samples, distributions, variables, hypothesis formulation and testing, t-test, ANVOA, and chi-square are presented through the lens of translational research. The course includes a detailed exploration of the application and interpretation of data from clinical trials and medical studies. The written and oral communication of study results is also covered.
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• RGAF 6200: Regulatory Drugs & Biologics

  2.00 Credits

  Weber State University

  
  This course focuses on the development and evaluation of regulatory practices related to drugs and biologics. This course provides an overview of laws and regulations governing development, manufacturing and distribution of drugs and biologic and how they relate to the regulatory affairs strategy. Approaches for integrating regulatory and business needs are reviewed. The role of post-marketing efforts in shaping regulatory strategy are evaluated. Prerequisite:    RGAF 6000
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• RGAF 6230: Regulatory Devices/Diagnostics

  2.00 Credits

  Weber State University

  
  An in-depth exploration of the origins and application of regulations relevant to medical devices and diagnostics. Medical device and diagnostic product development is covered through an organizational strategy and regulatory compliance lens. The course analyzes the design and application of clinical trial data related to the medical device and diagnostic regulatory process. Post-marketing strategy and device labeling are also covered. Prerequisite:    RGAF 6000
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• RGAF 6250: Regulatory Clinical Evidence

  2.00 Credits

  Weber State University

  
  The evaluation and assessment of regulatory strategies that include protocol development, study design, post-marketing surveillance, evaluation and, assessment of regulatory submissions. Utilizing clinical trial design, participants will evaluate and assess strategies for achieving regulatory goals. Students are introduced to requirements of planning and conducting clinical trials. Clinical trial terminology and design are discussed including planning and carrying out a study. Prerequisite:    RGAF 6000
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