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| TLI 52300 - Quality Management, Audits And Inspections |
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Credit Hours: 3.00. This course provides advanced topics in quality management and business improvement methods that apply to the pharmaceutical industry. Emphasis will be placed on specific issues of industry, audits, and inspections, as well as the successful selection and presentation of business and quality improvement projects to produce compliance and competitive advantage. Typically offered Fall Spring Summer.
0.000 OR 3.000 Credit hours Syllabus Available Levels: Undergraduate, Graduate, Professional Schedule Types: Distance Learning, Lecture, Recitation 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. 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). 2. Ability to meld theory and practice in regulatory affairs. 3. 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. 4. Read, write, speak, listen, and use data, media and computers to send and respond effectively to communication for varied audiences and purposes. 5. Demonstrate sensitivity to and facility with personal values and ethical principles in professional and social contexts. 6. Recognize the factors that influence regulatory decisions, develop methods to incorporate regulatory trends and practices, and think strategically about product development and marketing. 7. Examine quality systems and standards and their impact on public safety as well as the reliance on quality by health care providers. Restrictions: Must be enrolled in one of the following Colleges: Graduate School College of Pharmacy Doctor of Pharmacy May not be enrolled as the following Classifications: Junior: 75 - 89 hours Professional First Year Freshman: 15 - 29 hours Sophomore: 30 - 44 hours Sophomore: 45 - 59 hours Junior: 60 - 74 hours Freshman: 0 - 14 hours |
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