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| TLI 52500 - Molecular Basis Of Manufacturing Pharmaceuticals |
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Credit Hours: 3.00. This advanced course addresses important Chemistry Manufacturing and Control (CMC) issues related to process analytical technology. The course provides important information on strategies for monitoring processes on-line, the best approaches to analyzing data, how the data can be used to find process critical control points, and strategies for reporting the data to the FDA. The course may include laboratory exercises, laboratory tours, and/or workshops outlining how to interpret the data. Typically offered Fall Spring.
0.000 OR 3.000 Credit hours Syllabus Available Levels: Undergraduate, Graduate, Professional Schedule Types: Distance Learning, Individual Study, Laboratory, Lecture Offered By: College of Technology Department: Technology Ldrshp & Innovatn Course Attributes: 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: May not be enrolled as the following Classifications: Sophomore: 45 - 59 hours Sophomore: 30 - 44 hours Freshman: 0 - 14 hours Freshman: 15 - 29 hours |
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