Consumer education about prescription medications is controlled through FDA training requirements.
The U.S. Food and Drug Administration (FDA) is a consumer protection agency whose mission is to protect public health. This federal agency -- a consumer watchdog -- alerts people about recalls and warnings of foods, drugs, medical devices and cosmetics. Because FDA regulations are mandatory standards, the agency requires food and drug manufacturers to complete training courses to ensure consumer safety.
Training Documentation
FDA-regulated companies are required to document what training they administer to their employees. Such companies must also keep documentation on when all the training requirements are completed. This legal requirement attempts to control products that pose a potential threat. Food and prescription medications are considered potential threats because people consume them; therefore, these items have the power to affect a person's livelihood or quality of life.
Current Good Manufacturing Practices
Manufacturers must establish and follow quality systems for FDA-regulated products; the FDA refers to these quality systems as "current good manufacturing practices," or CGMP. Several third-party vendors administer CGMP training. The training centers around procedures that are required to maintain industry devices, such as medical syringes or microscopic surgical tools. The courses also cover the design of a corrective and preventative action program -- particularly important for manufacturers of medical gloves who must ensure their products have a very low level of defects to prevent infection.
State, Local and Federal Officials
The FDA administers required training for state, local and federal officials who may be involved in food and drug inspections. A training course is devoted to milk pasteurization and properly evaluate a plant's production system to ensure the system is producing a safe product. Other courses cover retail food establishments, including proper food storage and sanitation. Veterinary medicine training prepares officials to recognize animal diseases and tissue residues that violate FDA policy.
Health Professionals
Training for health professionals covers the history of drug regulation, interpret medication facts and warnings, get FDA approval for a medication and other topics related to patient safety. The risks associated with taking prescriptions is also covered. Additional training exists to educate professionals about reducing patient exposure to radiation from medical devices and the proper use of such devices.
Tags: food drug, medical devices, prescription medications, quality systems, training requirements
