Pharmaceutical Manufacturing Hands-On Short Courses

The FDA's Center for Drug Evaluation and Research seeks a contractor to deliver pharmaceutical manufacturing hands-on short courses for up to 40 personnel, with proposals due August 4, 2026 at 12:00 PM ET. This is a Firm Fixed Price procurement with no set-aside.

Place of performance is Silver Spring, Maryland. The contract calls for five in-person, 8-hour training sessions covering unit operations including tableting, aseptic processing, granulation, lyophilization, fermentation, ultrafiltration/diafiltration, filling, and film-coating. Instruction must span raw material assessment through end-product testing and quality control, including equipment setup, operation, cleaning, maintenance, process control, and identification of quality-critical variables.

The contractor must possess direct pharmaceutical manufacturing experience in solid oral, aseptic, or biopharmaceutical manufacturing; deep knowledge of regulatory and scientific frameworks governing pharmaceutical manufacturing, including FDA regulations on process validation, PAT, data integrity, and quality systems; demonstrated experience developing and delivering adult learning curricula preferably to regulatory audiences; and at least 3 years of professional teaching experience on the requested topics with required certifications. The contractor must provide an approved plan ensuring compliance with 28 CFR part 36 disability access standards prior to training commencement.

Deliverables include training materials (book/eBook and homework), pre-training reading packages, case study materials, resource lists of FDA guidances and ICH guidelines, knowledge checks, and certificates of completion. Payment occurs upon successful completion and Government acceptance of each training session. The period of performance is within one year from contract award. Evaluation is conducted on a Pass/Fail basis for technical acceptability, with award to the lowest-priced acceptable offer. Proposals must be submitted electronically in two volumes: Volume I (technical proposal with instructor resumes, curriculum alignment, and past performance references) and Volume II (price proposal). The contracting officer is Kyle Smith. The NAICS code is 813920, Professional Organizations; PSC is AN21, Health R&D Services; Health Research And Training; Basic Research.