CGMP for Dietary Supplements

The FDA regulates both finished dietary supplements and dietary ingredients to ensure they are appropriately labeled and safe for the consumer. Described in 21 CFR 111, these regulations provide for consistency in the identity, purity, quality, strength, and composition of dietary supplements. This lecture-based course provides training on 21 CFR 111 and the Current Good Manufacturing Practices (CGMPs) in manufacturing, packaging, labeling, and holding operations for dietary supplements. Attention is given to the sixteen subparts, regulatory compliance, and maintaining a culture of quality.

Suggested audiences include employees of CGMP-compliant environments such as personnel and service providers involved in the manufacture, testing, packaging, labeling, and/or holding of dietary supplements, including (but not limited to) technicians, specialists, and supervisors working in quality assurance, quality control, production, manufacturing, packaging, labeling, research and development, facilities, management, marketing, regulatory affairs, suppliers, and distributors.