Food and Drug Administration (FDA) Regulatory Compliance Training

This requirement provides competency training for personnel involved in FDA regulated research activities. The USAMRDC requires FDA regulated training in the areas of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Systems Regulations (QSR).

Background: The purpose of USAMRDC research and development activities is to provide FDA-approved pharmaceuticals and devices or licensed biologics to members of the United States (U.S) Military. These activities are governed by Federal, Department of Defense (DoD), and Army regulation and result in submissions to the FDA for eventual approval or licensure. Those research and development activities are subject to the compliance requirements of the FDA.

The requirements defined in Title 21, Code of Federal Regulations (21 CFR), parts 50, 58, 211, 600, and 820, require all individuals engaged in the conduct or supervision of FDA-regulated studies have education, training, and experience, or a combination thereof, to enable the individual to perform the assigned functions. Therefore, the Command must have in place, as part of its Quality efforts, a compliance program that includes minimum standards for training of all personnel involved in FDA-regulated activities.

Training requirements are outlined in accordance with USAMRDC Command Policy Memorandum 2013-60 Requirement for Training of Personnel Involved in FDA-Regulated Activities. The USAMRDC Headquarters Principal Acquisition Assistant serves as the FDA regulated Sponsor Representative, the responsibility for fulfilling FDA regulated sponsor responsibilities, and providing this training for other Subordinate Commands. USAMRDC ORA will provide technical oversight, guidance, and management of this requirement.

Objective: Assist personnel involved in FDA regulated product development throughout USAMRDC in maintaining competency in GCP, GLP, and cGMP to comply with U.S FDA and all other applicable DoD and Army regulations, directives, and guidance. The long-term objective of this training is to increase and maintain competency and compliance with FDA regulations governing product development efforts to meet our mission.