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Nov 05, 2025
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2025-2026 Catalog
Regulatory Affairs, Certificate
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 Return to: School of Advanced Manufacturing, Engineering & Applied Science
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PROFESSIONAL/TECHNICAL CORE
DEGREE OUTCOMES
- Demonstrate general as well as technical, regulatory, and scientific written communication skills.
- Demonstrate understanding of the FDA, including its history, organization, functions, publications, website structure, informational repositories, and utility in regulatory affairs.
- Demonstrate knowledge and understanding of clinical trial operations, including its role in the approval process of pharmaceuticals and medical devices.
- Demonstrate understanding of risk management elements and their implementation found in FDA.gov, ISO 14971, ICH Q9, ISO 13485, and ANSI.
- Demonstrate understanding of product life cycle elements and their implementation found in FDA.gov, ISO 14971, ICH Q9, ISO 13485, and ANSI.
- Choose one of three capstone projects, then create and deliver an artifact that incorporates the knowledge acquired throughout all of the Regulatory Affairs Certificate courses.
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Return to: School of Advanced Manufacturing, Engineering & Applied Science
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