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BIOL 5000: Regulatory Affairs for Life Sciences
4.00 Credits
Utah Valley University
Prerequisite(s): Acceptance into the Certificate of Proficiency in Regulatory Affairs for Life Sciences or Instructor Approval. Introduces regulatory affairs as practiced by medical device and biopharma companies in the US. Focuses on United States Federal Drug Administration and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidances and best practices.
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BIOL 5010: Quality Management Systems for the Life Sciences
2.00 Credits
Utah Valley University
Prerequisite(s): BIOL 5000. Introduces FDA and International Conference on Harmonisation (ICH) requirements for the QSR (Quality System Regulation). Focuses on ISO 13485 and related guidances. Specifically covers the regulations and standards which are the basis of the regulated life science industry.
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BIOL 5020: Design Control and Risk Management for the Life Sciences
3.00 Credits
Utah Valley University
Prerequisite(s): BIOL 5000. Introduces design control and risk management requirements for medical device and BioPharma companies.
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BIOL 525R: Advanced Topics for Biology Teachers
1.00 - 5.00 Credits
Utah Valley University
Prerequisite(s): Departmental Approval. For licensed teachers or teachers seeking to re-certify their biology endorsement from the Utah State Office of Education. Teaches principles of biology and pedagogy of teaching biology for teachers in public or private schools. Emphasizes correlation with the Utah Core Curriculum, the National Science Education Standards, and the Benchmarks of Project 2061. Topics will vary.
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BIOL 579R: Special Topics
2.00 Credits
Utah Valley University
Focuses on issues that are current and often changing in regulatory affairs, such as international regulations. Engages students in discussion and lectures with industry experts on cutting-edge issues that impact how medical devices and pharmaceuticals are regulated for compliance and safety. May be repeated for a maximum of 8 credits toward graduation.. May be delivered online.
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BIOL 580R: Capstone Project
1.00 Credits
Utah Valley University
Prerequisite(s): BIOL 5020. Applies knowledge learned in the Regulatory Affairs sequence of courses to the real world. Allows students to work with faculty members and industry experts to design and complete a project that incorporates various concepts that have been presented in previous Regulatory Affairs courses. May be repeated for a maximum of 3 credits toward graduation.
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BIOL 581R: Biology Internship
1.00 - 5.00 Credits
Utah Valley University
Prerequisite(s): Instructor Approval and Internship Orientation. Allows students to earn credit while obtaining practical and research experience as an intern in a government, nonprofit, private agency, or with an approved employer. Must be supervised by agency representative and faculty advisor. Department chairperson approval required and written contracts must be completed and signed. May be repeated with a maximum of 5 credits counting toward graduation. May be graded credit/no credit..
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BIT 1010: Building Codes
3.00 Credits
Utah Valley University
Teaches the nonstructural standards of the Uniform Building Code. Includes occupancy classifications, building area, height and location limits, exit requirements, and fire-resistive standards.
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BIT 1020: Residential Codes
3.00 Credits
Utah Valley University
Teaches the nonstructural standards of the International Residential Code. Includes foundations, walls, floors, roofs, finishes, heating, cooling, plumbing and electrical codes as they apply to residential construction.
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BIT 1230: Plan Review
3.00 Credits
Utah Valley University
Prerequisite(s): BIT 1010 or instructor's approval.. Designed to introduce students to the techniques of nonstructural plans examination through familiarization of the plan and construction documents, specifications, and the application of code requirements.
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