Regulatory Leadership in Food Law
Course Code: FSC 820
Credits: 3 credits
In the modern regulatory state, the attorney or regulatory affairs manager is looked to for counseling on more than just the meaning of the letter of the law but also for guidance and leadership in dealing with agencies, particularly in complex or difficult situations.
This course provides skill development for leadership in food regulatory issues, including working with government agencies in adverse or high-stakes situations, achieving the central purpose of regulation, and the control of risks to the public. All reading assignments will be available as downloads within the modules or via the provided URLs. The course syllabus is subject to change each semester but generally covers the following topics:
- Introduction to regulatory affairs
- Regulatory Analysis
- Critical Analysis, Science, and the Law
- Working with Government Officials
- Registrations and Submissions
- Staying Current with Changing Laws and Emerging Issues
- FDA Enforcement
- Dealing with Recalls
- Risk Management, Crisis Management
- Food Litigation Strategies
- Effectively Presenting Regulatory Information
- Quality Control, Quality Management
- The Regulatory Craft
This course is offered in the fall semester.
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