With this updated two-day program, you learn the fundamentals of the laws and regulations that affect all Food and Drug Administration (FDA)-regulated products: food, drugs, biologics, medical device and radiological health, veterinary products, dietary supplements and cosmetics. This course is designed to provide you with an overall landscape of food and drug law. It also includes information on how the newly passed legislation, the Food and Drug Administration Amendments Act of 2007 (FDAAA), impacts the industries.
From the difference in regulations for over-the-counter (OTC) and prescription (Rx) drugs to requirements of food manufacturing and nutrition labeling, this meeting walks you through the major regulations to help you develop a clearer understanding and working knowledge of all FDA products. You gain a broad overview of FDA, and the history and details of specific areas of regulations, including international issues. Additionally, you learn about United States Department of Agriculture (USDA), Federal Trade Commission (FTC), Centers for Medicare and Medicaid Services (CMS), U.S. Department of Justice, and other government agencies, and how they implement and enforce the regulation of foods and pharmaceuticals, medical devices and radiological health, veterinary medicine, dietary supplements, cosmetics, and biological and biotechnology products. The basic regulatory requirements that may arise when developing, processing, labeling, distributing, and competitively marketing various kinds of food and therapeutic products, is also discussed. Learn how FDA implements and enforces the laws enacted by Congress and how all of this affects what you do every day.
Approximate run time 13.5 hours.