Advanced Manufacturing Technologies In-Person Training Program

The Food and Drug Administration's Center for Drug Evaluation and Research seeks an in-person training program on advanced pharmaceutical manufacturing technologies, 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 the FDA White Oak Campus in Silver Spring, Maryland. The contractor must deliver four in-person training sessions, each not exceeding three days or seven hours daily, within one year of contract award. Content must address foundational knowledge of continuous manufacturing, additive manufacturing, and platform/modular systems; application of existing CGMP regulations and ICH guidelines (Q9, Q10, Q12, Q13); quality systems and Process Analytical Technology implementation; and practical case studies with inspection readiness assessment. Each session requires scientific and engineering principles instruction, real-world case studies or hands-on activities, and knowledge check assessments.

Deliverables include a training plan, four in-person sessions with final knowledge checks, completion certificates, pre-training reading packages, case study materials, and curated resource lists of FDA and ICH guidance documents. The contractor must possess a minimum of three years of professional experience teaching advanced manufacturing topics, demonstrate deep familiarity with regulatory frameworks and ICH guidelines, hold required certifications, and preferably have experience training regulatory or scientific audiences. Price must include all instructor labor, travel, and student materials with no separate reimbursement authorized. Payment is upon successful completion and Government acceptance of each training session submitted through the Integrated Procurement Process.

Technical proposals are evaluated on a Pass/Fail basis requiring instructors with three years experience and required certifications, curriculum alignment with all PWS learning objectives, and minimum two references for similar training delivered within the past five years. Award will be made to the lowest-priced proposal meeting technical acceptability standards without trade-offs permitted. NAICS code is 813920, Professional Organizations; PSC is AN21, Health R&D Services; Health Research And Training; Basic Research.