Dietary Supplements 21 CFR Part 111 Training North America

This course will provide participants with the knowledge to understand GMP for Dietary Supplements 21 CFR 111.

Course Description:
This course will provide an overview of the history of regulations, registration requirements, and provide knowledge of the 21 CFR subparts. The US FDA requires persons who manufacture, package, label, or hold a Dietary Supplement to establish and follow current Good Manufacturing Practices (GMP) to ensure the safety and quality of the Dietary Supplement and to ensure that the Dietary Supplement is packaged and labeled correctly. Our training will review the basic principles of an FDA inspection and give you the tools to navigate the process.

Learning Objectives:

• History of Regulations
• Registration requirements
• 21 CFR Part 111 subparts (Subparts B-P)
• SOPS and SSOPs
• Critical FDA violations
• Major FDA GMP violations
• Major FDA Label violations

Who should attend?
Dietary supplement manufacturers; dietary supplement brand owners; executives responsible for navigating an FDA inspection; employees who will participate in the FDA inspection.

Certificate
Upon successful completion, participants will receive a Certificate of Completion.