Performance Period: 1/2/2019 to 7/2/2019
The necessity of FDA reviewers and auditors to possess comprehensive knowledge of the manufacturing process is vital to pharmaceutical approvals with all manufacturing processes being verified and validated. The emergence of gene therapy, cell therapy, advanced automation, and other bioprocess innovations poses potential challenges for FDA personnel who must keep abreast of industry innovations. This project is focused on the planning of a comprehensive training solution. The project team will evaluate existing training facilities, existing FDA training programs at these facilities, as well as input from FDA and industry to
Not yet a member? Learn more about which level of NIIMBL membership is right for you and your organization.
University of Maryland College Park