The Dietary Supplement cGMP Rule (21 CFR part 111)

Overview:

FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):

• Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations
• FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market

Why you should Attend: 

To gain a fundamental understanding of dietary supplement cGMPs .

Areas Covered in the Session:

• Definition of dietary supplement
• DSHEA
• Current Good Manufacturing Practices

Who Will Benefit:

• Regulatory Professionals Working in the Field of Dietary Supplements
• Compliance Manager
• Validation Manager
• Regulatory Manager
• QC Managers
• QA Managers