Orientation to GMP Compliance

Many people, including those who work in the drug and medical device industries, find regulations confusing. Because FDA regulations have a direct impact on how you do your job, this interactive program is designed to take the mystery out of these regulations by giving you insight on how they are applied and interpreted. You will better understand how the FDA and your own company’s compliance professionals interpret and apply these important regulations. Upon completion of this lesson you will be able to explain how the Food, Drug, and Cosmetic Act are tied to the Code of Federal Regulations Title 21, and how the GMPs are key elements in those regulations. In addition, you will understand how various FDA publications aid in interpreting and determining the FDA’s expectations in regards to these regulations.