Advanced Manufacturing Technologies In-Person Training Program

FDA-26-PWS-135129 Statement of Work In-Person Training Program – Advanced Manufacturing Technologies 1. BACKGROUND Advanced manufacturing technologies — including continuous manufacturing, additive manufacturing, along with platform and modular technologies — represent a significant evolution in pharmaceutical production. These technologies offer the potential to increase manufacturing flexibility and strengthen supply chain resilience. FDA has actively encouraged the adoption of advanced manufacturing technologies through FDA's Advanced Manufacturing Working Group published report, the Modernizing Pharmaceutical Manufacturing initiative, and the Emerging Technology Program. As FDA staff are increasingly called upon to review, inspect, and develop policy related to facilities utilizing advanced manufacturing technologies, it is essential that CDER employees develop a strong foundational understanding of the scientific and engineering principles underlying these technologies, as well as the regulatory frameworks that govern them. In-person training delivered by subject matter experts is requested to promote active engagement and facilitate the applied, discussion-based learning that advanced manufacturing topics require. 2. PURPOSE AND OBJECTIVES The purpose of this contract is to engage subject matter experts (SMEs) to deliver in-person training on advanced pharmaceutical manufacturing technologies for employees in CDER. The training is intended to build staff capacity to effectively review, inspect, and develop policy related to facilities and products utilizing advanced manufacturing approaches. The objectives of this training are as follows: • Develop foundational understanding of advanced manufacturing technologies — Participants will gain a working knowledge of the scientific and engineering principles underlying key advanced manufacturing modalities, including continuous manufacturing, 3D printing of drug products, and platform and modular manufacturing systems, with emphasis on how these technologies differ from traditional batch manufacturing in design, operation, and quality control. • Apply regulatory frameworks to advanced manufacturing contexts — Participants will examine how existing CGMP regulations and international guidelines — including ICH Q13, ICH Q9, and ICH Q10 — apply to advanced manufacturing processes and will develop familiarity with areas where regulatory flexibility or additional guidance may be warranted. • Build applied skills through case study analysis — Participants will engage with real- world and hypothetical case studies drawn from advanced manufacturing contexts, including continuous manufacturing deviation investigations, real-time release testing -- 1 of 7 -- scenarios, and 3D-printed drug product review situations, to develop practical analytical skills applicable to their regulatory duties. • Strengthen inspection and compliance readiness — Participants will develop an understanding of how advanced manufacturing operations are assessed during FDA inspections, including common findings, emerging best practices, and the application of Process Analytical Technology (PAT) and real-time release testing frameworks. 3. SCOPE OF THE WORK The advanced manufacturing training program shall offer four in-person sessions. The length of each session will be commensurate with the topic, not exceeding a maximum length of three days or daily maximum of seven hours for each session. Requirements for each training session: • Deliver in-person training on advanced manufacturing topics • Address the scientific and engineering principles underlying the session's technology focus • Incorporate case studies or hands-on activities drawn from real-world advanced manufacturing scenarios • Include knowledge check questions Example Session Topics: In-Person Session #1 — Introduction to Advanced Manufacturing Technologies: Overview of key advanced manufacturing modalities (continuous manufacturing, 3D printing, platform and modular technologies), their benefits, current industry adoption, and implications for pharmaceutical quality and supply chain resilience. In-Person Session #2 — Regulatory Framework for Advanced Manufacturing: Examination of how existing regulatory requirements and international guidelines — including ICH Q9, ICH Q10, ICH Q12, and ICH Q13 — apply to advanced manufacturing processes, including areas of regulatory flexibility and emerging policy considerations. In-Person Session #3 — Quality Systems and Process Analytical Technology (PAT) in Advanced Manufacturing: Application of quality risk management principles and PAT tools to advanced manufacturing processes, including real-time release testing, control strategy development, and data integrity considerations specific to continuous and novel manufacturing systems. In-Person Session #4 — Case Studies and Inspection Readiness for Advanced Manufacturing: Applied case study analysis of advanced manufacturing operations from a regulatory perspective, including review of inspection findings, common compliance challenges, and best practices for assessing advanced manufacturing facilities. 4. DELIVERABLES -- 2 of 7 -- • Training plan describing proposed topics, materials, speakers, and approach • Four in-person training sessions, including a final knowledge check quiz or exam • Certificates of completion to be maintained as part of the training record • Pre-training reading package or background materials for each session to establish baseline knowledge among participants • Case study materials tailored to advanced manufacturing scenarios for use during training sessions • A curated resource list of relevant FDA guidances, ICH guidelines, and key scientific literature provided to participants following each session 5. CONTRACTOR QUALIFICATIONS • Direct experience with advanced manufacturing technologies, including continuous manufacturing, 3D printing of drug products, or platform and modular m…