Food and Drug Administration (FDA) Regulatory Compliance Training
ID: PANDHA-25-P-002528Type: Sources Sought
Overview

Buyer

DEPT OF DEFENSEDEFENSE HEALTH AGENCY (DHA)ARMY MED RES ACQ ACTIVITYFORT DETRICK, MD, 21702, USA

NAICS

All Other Professional, Scientific, and Technical Services (541990)

PSC

SUPPORT- PROFESSIONAL: OTHER (R499)

Original Source

https://sam.gov/opp/a6ec63cde6b54d26b66aaec18cdce511/view
Timeline
    Description

    The Department of Defense, through the U.S. Army Medical Research and Development Command (USAMRDC), is seeking qualified vendors to provide FDA Regulatory Compliance Training for personnel involved in FDA-regulated research activities. The training will focus on Good Clinical Practices (GCP), Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and Quality Systems Regulations (QSR), ensuring that personnel maintain the necessary competency and compliance with U.S. FDA and Department of Defense regulations. This initiative is crucial for facilitating the development of FDA-approved pharmaceuticals and devices for military members, reflecting the government's commitment to research integrity and regulatory adherence. Interested vendors must submit a Capability Statement by February 5, 2025, and the anticipated contract will span one base year with four optional years, commencing around May 2025. For further inquiries, contact Matthew Gembe at matthew.w.gembe.civ@health.mil or call 301-619-1350.

    Point(s) of Contact
    Matthew Gembe
    (301) 619-1350
    matthew.w.gembe.civ@health.mil
    Files
    Title
    Posted
    A02. FDA Compliance Training_Performance Work Statement.docx
    The FDA Regulatory Compliance Training document outlines a requirement by the US Army Medical Research and Development Command (USAMRDC) to provide training for personnel involved in FDA-regulated research activities. The training encompasses Good Clinical Practices (GCP), Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and Quality Systems Regulations (QSR). The objective is to ensure personnel maintain competency and compliance with U.S. FDA and DoD regulations to facilitate FDA-approved product development for military members. The contract includes provisions for training sessions, both virtually and in person, set to commence around May 2025, with a base year and four optional years. It details performance requirements, including the development of training materials, obtaining necessary certifications for attendees, and producing comprehensive training reports. The contractor is responsible for conducting skill assessments, addressing training gaps, and ensuring quality instruction. Additionally, the document specifies management responsibilities, security requirements, contractor travel guidelines, and mandatory non-disclosure agreements. This training program is vital for maintaining regulatory compliance and enhancing the efficacy of research and development efforts within the military context. Ensuring proper training aligns with federal objectives of delivering safe and effective pharmaceuticals and devices.
    USAMRDC FDA regulatory Compliance Training RFI-Sources Sought.doc
    The U.S. Army Medical Research and Development Command (USAMRDC) has issued a Request for Information (RFI) to assess sources capable of providing competency training in FDA-regulated research activities, specifically in Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and current Good Manufacturing Practices (cGMP). This training is crucial for compliance with U.S. FDA and Department of Defense regulations. The anticipated contract will entail developing training materials and conducting classes to enhance regulatory knowledge among personnel. The project is planned to span one base year plus four optional years. Interested vendors are invited to submit a Capability Statement detailing their experience, expertise, and business information, including size classification and current government contracts. The submission deadline is by February 5, 2025. This initiative underscores the government's commitment to ensuring that personnel involved in regulated research are adequately trained to meet stringent compliance requirements, reflecting broader goals for research integrity and regulatory adherence across federal operations.
    Lifecycle
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    Type
    Food and Drug Administration (FDA) Regulatory Compliance Training
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