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Jun 16, 2025
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2025-2026 Catalog
Regulatory Affairs, Certificate
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PROFESSIONAL/TECHNICAL CORE
DEGREE OUTCOMES
- Demonstrate written communication skill in general as well as technical, regulatory, and scientific.
- Demonstrate understanding of the FDA.gov agency, history, organizational chart, functions, publications, website structure and informational repository and its usefulness in regulatory affairs.
- Demonstrate knowledge and understanding of Clinical Trial operation and its role in the approval process of medicinal products (medical devices and pharmaceuticals).
- 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. Chose one of three Capstone projects and create their chosen project using the knowledge acquired from all the previous regulatory affairs courses.
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