Advanced Manufacturing Technologies In-Person Training Program

The FDA Center for Drug Evaluation and Research is seeking a contractor to deliver four in-person training sessions on advanced pharmaceutical manufacturing technologies, including continuous manufacturing, additive manufacturing, and platform and modular systems, to support FDA CDER staff in enhancing regulatory review, inspection, and policy development capabilities. Each session is limited to three days at seven hours per day and must take place at the FDA campus in White Oak, Silver Spring, Maryland, within one year of contract award. The training must align with ICH Q9, Q10, Q12, and Q13 standards, as well as relevant FDA guidances on quality systems, process validation, PAT, and data integrity. Key deliverables include a comprehensive training plan, pre-training reading packages, tailored case studies, a curated resource list of FDA and ICH documents, certificates of completion for participants, and four fully executed training events with final assessments. All materials must be professionally prepared and submitted in formats specified by the Contracting Officer’s Representative, who will provide written acceptance within 15 business days of receipt. The contract is a Firm-Fixed-Price arrangement with no travel reimbursements, and all costs—including labor, materials, and administrative overhead—must be embedded in the total price proposed by the offeror. Proposals must be submitted in two sealed volumes: Volume I (Technical) containing instructor resumes, a detailed syllabus mapped to the Performance Work Statement, and at least two verifiable past performance references; Volume II (Price) containing a completed firm-fixed-price schedule with total cumulative pricing. Evaluation follows a Lowest Price Technically Acceptable process, where technical acceptability is a mandatory pass/fail gate based on instructor qualifications, curriculum alignment, and past performance, with only technically acceptable offers proceeding to price evaluation. The award will go to the lowest-priced technically acceptable offeror, with no trade-offs permitted. The contract includes stringent compliance requirements such as adherence to the Privacy Act, accessibility standards under 28 CFR Part 36, cooperation with EEO investigations, and prohibitions on certain telecommunications equipment and software. All payment requests must be submitted electronically via the Invoice Processing Portal under the System for Award Management, and the contractor must maintain active UEI registration and comply with all applicable FAR and HHSAR clauses, including those addressing executive compensation reporting, human trafficking prevention, cybersecurity, and non-retaliation provisions. No set-aside provisions apply, and the NAICS code is 813920. The contracting officer is Kyle Smith at kyle.smith@fda