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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.
Categories
Incumbent worker training
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.

Updates, Related Publications, and Deliverables

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Project Lead

University of Maryland College Park

University of Maryland College Park

Participating Organizations

North Carolina State University

North Carolina State University