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| ABE 51500 - Molecular Basis Of Manufacturing |
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Credit Hours: 3.00. This advanced course addresses important Chemistry Manufacturing and Control (CMC) issues related to manufacturing and quality by design. The course provides important information on strategies for quality by design, manufacturing strategies for early development, the best approaches to analyzing data, and strategies for reporting the information to the FDA. This course will also focus on product design and processing. Using product and process design helps achieve quality by design (QbD), strong development reports, excellent regulatory submissions and allows continuous improvement. The course includes laboratory exercises, laboratory tours, and/or workshops outlining how to interpret the data.
0.000 OR 3.000 Credit hours Syllabus Available Levels: Undergraduate, Graduate, Professional Schedule Types: Distance Learning, Lecture, Recitation Offered By: College of Agriculture Department: Ag & Biological Eng Program Course Attributes: Dept Credit, Upper Division May be offered at any of the following campuses: West Lafayette Continuing Ed West Lafayette 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. Restrictions: Must be enrolled in one of the following Programs: Agric Biol Engr-MS-ABE Must be enrolled in one of the following Levels: Graduate Must be enrolled in one of the following Concentrations: Biotech Innov & Regulatory Sci Prerequisites: ABE 51100 and ABE 51200 |
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