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| ABE 51300 - Quality Management, Audits, 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 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 quality management definitions, concepts, and guidelines. 2. Define quality and how to establish a quality management system. 3. Define quality plan, describe its purpose for the organization as a whole and identify various functional areas and people that have responsibility for contributing to its development. 4. Understand the audit process and quality control, including the various approaches to audits, inspections and reviews. 5. Understand basic skills required to manage audits, inspections and reviews. 6. Learn how to set up effective self audit systems. 7. Understand the impact of changing technologies, such as electronic systems, on supporting a quality management system. 8. Understand how quality management functions support global business decisions for asset acquisitions and growth of a company. 9. Understand the key elements of supply chain management, assessing risk, and managing outcomes from supplier and vendor audits. 10. Understand regulatory compliance aspects and implementation of ICH and global quality principles in supply chain management, including good distribution practices. 11. Define a continuous quality improvement or business improvement project within an organization. 12. Select and define continuous quality improvement tools and techniques in order to achieve operational excellence. 13. Develop in-depth knowledge of how to implement and obtain operational excellence and present the findings in a coherent and informative manner. 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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