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.
Participants in this course will:
• Learn the current Good Manufacturing Practices (cGMPs) in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements (21 CFR 111)
• Appreciate the importance of cGMPs as regulations designed to prevent harm to the user of the product
• Identify reasons why cGMPs are essential for all regulated industries
• List the ten fundamentals of Good Manufacturing Practices
• Apply methods for meeting the regulatory requirements of Dietary Supplements
This course is available online, and can be taken anytime, anywhere.
This course is also available live online (given online, at a prescheduled time, by a live instructor). The next live online course will be given on Wednesday, September 9, 2020, at 1pm ET.