Use this page to maintain syllabus information, learning objectives, required materials, and technical requirements for the course. |
ABE 51500 - Molecular Basis Of Manufacturing |
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Associated Term:
Spring 2020
Learning Outcomes: 1. Understand the conceptual foundations and approaches to good regulatory practices and comprehend strategies used in regulatory affairs. 2. Obtain and apply broad knowledge of FDA and international law, regulations, and guidance documents for at least one category of medical products (drugs, biological products, devices). 3. Ability to meld theory and practice in regulatory affairs. 4. Examine issues rationally, logically, and coherently; and acquire, evaluate, and synthesize information and knowledge relevant to an identified problem; and make sound decisions in both familiar and unfamiliar contexts. 5. Read, write, speak, listen, and use data, media and computers to send and respond effectively to communication for varied audiences and purposes. 6. Recognize the factors that influence regulatory decisions, develop methods to incorporate regulatory trends and practices, and think strategically about product development and marketing. Required Materials: Technical Requirements: |
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