Regulatory Leadership in Food Law
WELCOME to the preview for Regulatory Leadership in Food Law, FSC 890, Section 734. New spring semester 2017
This is a 3 credit hour, graduate level, Internet-based, college course offered by Michigan State University. The Lead Instructor is the Associate Director of the MSU Institute for Food Laws & Regulations Instructor Melissa M. Card along with expert guest lectures. There is also a Course Manager who will be available to help with any and all concerns regarding this course.
Regulatory affairs managers and attorneys in today’s world are looked to for counsel on more than just the meaning of black letter law, but also for guidance and leadership in dealing with agencies, particularly in adverse or high-stakes situations. This course will provide students with an introduction to regulatory affairs as these issues apply to the regulation of food. Among other concepts, this course will cover: the nature of the regulatory process; the role, ethics and practical application of regulatory affairs; tools and strategies; the nature of assessing and communicating risk; quality controls and management; compliance; and judicial review of agency decisions.
The learning objectives of this course are to enable students to:
- Understand the nature of the regulatory process as it pertains to food.
- Exaine the current issues in regulatory affairs.
- Utilize guidance documents to reach science-based or legal-based conclusions.
- Assess and develop risk management strategies that can be used to get new products to the market swiftly, while assuring the consumer and regulatory bodies that safety has been preserved.
- Explore the intersection of science and law.
- Develop leadership skills for overseeing research that is required by regulatory agencies.
The course is taught in a series of sections or ” Modules”. Each module lasts one week and represents a specific food law topic or issue. Each week a new module will be uploaded on Monday morning. You will have one week to read the materials, view the video, and complete the assignment. Once uploaded, the Modules remain online throughout the duration of the course so you can always go back in case you miss a week or need to refer to a specific topic.
The following topics may change each semester:
1. Introduction to Regulatory Affairs:
History of Regulatory Affairs in the USA, and Continued Evolution of Regulatory Affairs.
What Is Regulatory Affairs?:
Principles of Regulatory Affairs, Examples of Responsibilities, and Examples of Industries Using Regulatory Affairs.
2. The Role of Regulatory Affairs:
A Gatekeeper, an Advisor, or a Risk Manager; Examples of Regulatory Affairs Individual’s Roles Amongst Various Businesses; and How Regulatory Affairs Changes Based on Industry.
Short Guest Lecture: Ethics in Regulatory Affairs
3. Practical Application of Regulatory Affairs via Food Labeling and Health Claims:
Terminology; Affirmative Labeling; and Misbranding.
How Different Agencies and Countries Regulate Food Labeling:
How Labeling Products Differs with the FDA, USDA, or TTB; and How Labeling Products Differs by Country.
Legal Issues Surrounding Food Labeling:
Optional Labeling Information; Using Undefined Terms; and Risk of Litigation.
4. Guest Lecture: The intersection of science and law
5. Practical Application of the Regulation of Food Additives and Chemicals Used in the Food Industry:
FDA Food Additive Petition, GRAS Notification, and Color Additive Submission Process.
Practical Application of the Regulation of Genetically Engineered Products:
Overview; Food Safety; FDA Policy Concerning Genetically Engineered Products; USDA’s Role; EPA’s Role; and Different Perspectives Based Which Agency Is Regulating
6. Guest Lecture: Working with Government Officials in the U.S. and Internationall
7. Registration in U.S.A:
Overview and Registration of Food Facilities in U.S.
International Registration and Submissions to Governments:
Registering Food in International Countries to Include Certificates of Free Sale; FDA/USDA Export Certificate Documentation; and Other Requirements for Product Launches in Foreign Market
8. Staying Current with Changing Laws, Regulations, and Processes:
FDA Guidance Documents and Draft Guidance Documents; Comments; Searching for Warning Letters; 483 Inspection Reports; and CFR Title 21
9. Guest Lecture: How to manage risk communicatio
10. Effectively Presenting Information Within an Organization:
Present Information Effectively within Your Organization; Proven Communication Techniques; Presenting Information within the Context of Cost/Benefit/Risk Analysis.
Short Guest Lecture: How communication techniques differ based on the role of the Regulatory Affairs
11. Quality Control:
FDA Regulations on GMPs; Meaning of these Regulations, Globalization of Practices, and Roles and Responsibilities of Professionals Implementing these Regulations.
Overview; Audits and Inspections; Private Standards, Global Food Safety Initiative, and Third-Party Inspections.
U.S. Food and Drug Administration’s Office of Regulatory Affairs (ORA):
Overview of ORA’s Responsibilities, ORA’s Mission Statement, and ORA’s Collaboration with State, Local, Tribal, Territorial and Foreign Counterparts.
12. Guest Lectures –Compliance
13. Judicial Review of Agency Decisions:
Standards of Review; Constitutional Review; Specific Agency Review; and Review of Agency Inaction
14. FINAL EXAM
Your assignments will be due the following week and can be submitted automatically using our Course Assignment Drop Box feature or by email or fax. Grades are posted electronically and send to you by email. Class participation is accomplished by means of synchronous and asynchronous Internet communication technologies through written Discussion Forums or a Chat Room.
So there you have it. It should take an average of nine to twelve hours per week to complete a module. You simply go online each week and a new module will be waiting. Read the materials, explore the hyperlinked and other Internet-based resources, complete the assignment, upload it to the course assignment drop box, and you’re done for the week. Now, lets be realistic. What if you’re called out of town for a week or are otherwise unable to access or complete a module within the time limit? No problem. Time extensions can be granted; and if you give us a bit of notice, the course materials can be provided to you by fax or email attachment.
If you are looking for a convenient way to continue your education and you need information regarding regulatory leadership in food law, this is the course for you.
Just click here [How to Enroll] to get started. You will find a sample copy of the Application along with instructions to enroll directly online. No transcript submission is required through the Lifelong Education program.
This course is offered spring semester - odd years.
For more information, see the Course Schedule.
This course is one of the courses comprising our International Food Law Certificate Program sponsored by the Institute for Food Laws & Regulations, the Department of Food Science & Human Nutrition, and the College of Agriculture & Natural Resources at Michigan State University. The program provides a series of region-specific or topic-specific, Internet-based, food law courses designed for anyone who must understand the legal and regulatory complexities of the flow of food and agricultural products across national boundaries.