SAM #FDA-26-PWS-135129

FDA CDER Solicits In-Person Training on Advanced Pharmaceutical Manufacturing Technologies

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is seeking a contractor to deliver in-person training on advanced pharmaceutical manufacturing technologies. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Center for Drug Evaluation and Research (CDER) - Contracting Officer: Kyle Smith - Services Requested: - Four in-person training sessions (up to three days each, seven hours per day) - Topics: continuous manufacturing, 3D printing (additive manufacturing), platform and modular manufacturing systems - Coverage includes scientific principles, regulatory frameworks (ICH Q9, Q10, Q12, Q13), quality systems, and inspection readiness - Deliverables: training plans, session materials, quizzes, certificates, and instructor labor (including travel and materials) - Unique Requirements: - Contractor must demonstrate expertise in advanced manufacturing and regulatory training for pharmaceuticals - Training must address both technical and regulatory aspects relevant to FDA staff - No specific OEMs or product part numbers are mentioned - Firm-fixed-price contract structure

Description

Requiring training in 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. 

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