Dietary Supplement Testing and Specifications Seminar

Specifications and testing remain among the most frequently cited deficiencies during FDA inspections of dietary supplement manufacturers. While the requirements of 21 CFR Part 111 have been in place for years, many firms continue to struggle with developing scientifically sound specifications, implementing appropriate testing programs, and documenting compliance.

This four-hour seminar provides an in-depth examination of FDA requirements for dietary supplement specifications and testing, with practical guidance drawn from EAS Consulting Group’s regulatory and industry experience and direct FDA interactions. Participants will gain a clearer understanding of FDA expectations for component, in-process, packaging, labeling, and finished product specifications, along with the testing necessary to demonstrate compliance.

Beyond reviewing the regulations, this seminar explores the real-world questions companies face every day, including when reduced testing may be appropriate, whether “testing by input” can satisfy regulatory requirements, how to develop rotational testing programs for finished products, and how recent FDA inspection trends continue to shape industry expectations.

Whether you are responsible for quality, regulatory affairs, manufacturing, or product development, this seminar will help you better evaluate your current specifications program and identify opportunities to strengthen compliance before your next FDA inspection.

Topics Covered

• Understanding specification requirements under 21 CFR Part 111
• Component specifications and identity testing
• In-process specifications and manufacturing controls
• Packaging and labeling specifications
• Finished product specifications and testing requirements
• Reduced testing—when is it appropriate?
• “Testing by input”—what FDA expects
• Developing defensible rotational testing programs
• Common FDA inspection observations involving specifications and testing
• Practical approaches for maintaining a compliant specifications program

Who Should Attend

• Quality Assurance and Quality Control professionals
• Regulatory Affairs personnel
• Manufacturing and Operations managers
• Laboratory managers
• Product Development teams
• Dietary supplement manufacturers
• Contract manufacturers
• Brand owners and private label companies

Additional Information

Participation in this event will include the Dietary Supplement Labeling Handbook.

Looking for a deeper dive?

If you attended our complimentary webinar on Dietary Supplement Finished Product Testing and Specifications, this seminar expands on those concepts with detailed discussion, practical examples, and additional time for questions and discussion.

About the Instructor

Shelly Blackwell

Senior Director for Dietary Supplement and Tobacco Services

Shelly Blackwell brings over 22 years of quality and compliance experience in highly regulated environments to the EAS Consulting Group. After starting her career as a Microbiologist, she gained expert knowledge of a variety of domestic and international regulations while holding senior leadership positions in the dietary supplement, pharmaceutical, and medical device industries. These positions include 7 years as the Quality Assurance Director for GNC / Nutra Manufacturing and most recently leading the Quality Systems and Compliance Team at Bausch and Lomb in Greenville, SC.

Shelly’s accomplishments while leading Quality teams include developing supplier qualification programs, sourcing and implementing electronic QMS systems, implementing inspection readiness programs resulting in improved regulatory standing, risk-based quality system development, data integrity program development, and numerous successful continuous improvement initiatives. She has lead FDA and other regulatory inspections throughout her career and is also a lead auditor herself, auditing raw material suppliers and finished product manufacturers all over the world. Shelly holds certifications from the American Society of Quality and the Institute of Food Technology and has a Biology degree from James Madison University.