A deep understanding of current Good Manufacturing Practices (GMPs) is essential for dietary supplement industry stakeholders, particularly as regulatory priorities continue to evolve. With continued scrutiny from enforcement agencies and industry watchdogs, and uncertainty around regulatory expectations amidst the shifting administration – ensuring GMP compliance is more critical than ever.

This Boot Camp will equip dietary supplement companies and their legal teams with a comprehensive understanding of 21 CFR 111 and best practices for preparing for GMP inspections and responding to GMP observations in 483s or Warning Letters. As the regulatory landscape continues to shift, participants will gain practical insights into staying ahead of compliance challenges and mitigating enforcement risks.

Key topics include:

• Breaking down 21 CFR 111: Understanding the full scope of U.S. dietary supplement GMP regulations
• Discussion GMP areas of regulatory focus
• Core compliance responsibilities: What brand owners, manufacturers, packers, labelers, and distributors need to know and how to focus compliance resources
• Applying GMP requirements in practice: Strategies for ensuring compliance at your facility
• Preparing your site for an FDA inspection – tips and tools
• Analyzing you 483 – how significant is it?
• Best practices when responding to 483 observations and Warning Letters
• What makes a “good” response? – an interactive session that reviews hypothetical observations and potential poor, average and excellent responses
• Regulatory enforcement trends: Analyzing recent FDA Form 483 observations and Warning Letters
• What are the most commonly cited issues?
• The potential impact of regulatory changes: How a new administration could influence FDA priorities and enforcement in the dietary supplement space