Pharmaceutical Manufacturing Hands-On Short Courses

The contract solicits a provider to deliver five 8-hour in-person training sessions on pharmaceutical manufacturing unit operations to up to 40 FDA staff members, with a focus on hands-on and lecture-based learning covering tableting, aseptic processing, granulation, lyophilization, fermentation, ultrafiltration/diafiltration, filling, and film-coating. The training must be conducted within one year of contract award at a facility identified by the contractor, with the official place of performance in Silver Spring, Maryland. The solicitation requires a firm-fixed-price contract under the Lowest Price Technically Acceptable (LPTA) evaluation method, where technical acceptability is a Pass/Fail threshold assessed through instructor qualifications, curriculum alignment with the Performance Work Statement, and at least two verifiable references of similar training delivered within the past five years. Offerors must submit a two-volume proposal: Volume I containing detailed instructor resumes, a syllabus aligned to specified learning objectives, and past performance documentation, and Volume II containing a complete price schedule covering all labor, materials, travel, and overhead costs. Delivery of training materials including a pre-training reading package, case studies, a curated resource list of FDA and ICH guidance documents, certificates of completion, and knowledge checks is required, with all outputs subject to Government acceptance within 15 business days of submission. Invoicing must be done electronically through the Integrated Payment Platform (IPP), and the contractor must comply with accessibility standards under 28 CFR Part 36, Privacy Act requirements for handling personally identifiable information, and HHS-specific provisions on equal opportunity and subcontractor reporting. All offerors must maintain an active UEI and CAGE Code in SAM.gov and submit proposals electronically by the August 4, 2026 deadline to the designated Contracting Officer.