 | Use this page to maintain syllabus information, learning objectives, required materials, and technical requirements for the course. |
| TLI 52300 - Quality Management, Audits And Inspections |
|---|
|
Associated Term:
Summer 2015
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. Required Materials: Technical Requirements: |
| Return to Previous | New Search |
 |