CINF 14 |
| Working as a chemist at the FDA is probably one of the least understood career paths available to chemists today. This talk will provide a general overview of the FDA drug approval process with an emphasis on the chemist's role in the scientific reviewing divisions as well as their role in the evaluation of current Good Manufacturing Practices (cGMPs). As Regulatory Review Scientists, chemists evaluate the chemical sections of drug applications. This evaluation includes an assessment of the adequacy of the methods, facilities, and controls used for the manufacture of drugs. As Consumer Safety Officers (commonly referred to as investigators within FDA), chemists audit, review, and evaluate the manufacturing processes of products that the FDA regulates by inspecting manufacturing facilities within the United States and abroad as well as work as members of multi-disciplinary teams to assure efficient enforcement of the Food Drug and Cosmetic (FD&C) Act. |
|
Careers in Chemical Information
8:30 AM-11:50 AM, Sunday, 26 March 2006 Georgia World Congress Center -- B303, Oral
Division of Chemical Information |