Biopharmaceutical Manufacturing for the FDA

The project team will evaluate existing training facilities, existing FDA training programs, as well as input from FDA and industry to 1) identify training gaps and 2) develop a plan for aligning training resources and developing curriculum.

Project status

100% Completed

Solution

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

identify training gaps; and,
develop a plan for aligning training resources, and
developing curriculum material to fill these gaps.

Impacts

Identification of potential in advanced cell and gene therapy manufacturing training for the regulatory workforce

Assessment of existing training opportunities and identification of gaps and unmet needs in regulator training opportunities

Additional Project Information (Members Only)

Updates
Value Proposition
Related Publications
Deliverables

Not yet a member? Learn more about which level of NIIMBL membership is right for you and your organization.

Project Lead

University of Maryland College Park

Participating Organizations

North Carolina State University