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Guidance for Addressing FDA cGMP Inspections of Dietary Supplement Facilities

Understand your rights and obligations when FDA conducts a cGMP inspection

AHPA members, log in to access this document at no charge. This guidance is designed to help AHPA members in understand their rights and obligations when the FDA conducts an inspection of a dietary supplement facility. It provides descriptions and analyses of the current federal laws that are relevant to inspection of dietary supplement facilities and suggestions of how to prepare for and conduct inspections in a manner that fully complies with these laws.

cGMP Compliance Series: How to Conduct & Manage a FDA Inspection

Presented: July 30, 2009

This webinar covers the extent of FDA's authority during an inspection, so you know your rights.

cGMP Compliance Series: Record Keeping, Document Control & How to Write SOPs

Presented: May 28, 2009

Learn how to create, manage and control documents for good GMP practices, inspectors, auditors and safety.

CGMP Compliance Series: Setting and Meeting Specifications for Contaminants in Finished Products

Presented: January 22, 2009

Under the cGMP rule, it is the responsibility of the manufacturer to identify contaminants likely or certain to be present in or on components received and to establish limits to prevent adulteration of these components.

Sustainability & Crafting Responsible "Green" Marketing

Presented: September 18, 2008

An expert panel provide practical. first-hand knowledge and answer questions about sustainability and how to walk the walk in a “greenwashed” world.

Shelf Life Statements on Dietary Supplements

Presented: May 22, 2008

The new Good Manufacturing Practice regulations for dietary supplements require that manufacturers with shelf life statements on their labels have appropriate scientific substantiation

Debriefing the FDA's cGMP Implementation Seminar

Presented: October 25, 2007

This debriefing provides expertise to answer specific questions and dispel any confusion that arose from the FDA overview of cGMP implementation guidance.

Serious Adverse Event Reporting (SAER): Strategies for Compliance

Presented October 16, 2007

AHPA presents strategic regulatory, medical and legal perspectives to help companies comply with the Dietary Supplement and Nonprescription Drug Consumer Protection Act

cGMP Compliance Series: Good Manufacturing Practices: The Final Rule

Presented: July 12, 2007

This educational event will help you learn exactly what you need to know about the dietary supplement cGMP requirements, including the necessary processes and procedures need to ensure compliance.

Structure/Function Claims: Crafting Smart & Lawful Marketing Info & Labels

Presented: June 28, 2007

The limits placed on what you can and cannot claim about your product are key elements of the laws that affect dietary supplements. Every marketing plan must balance what federal law allows, what is informative to consumers, and what may drive sales.


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