Dietary Component Specifications and Testing

Presented by Shelly Blackwell

May 21, 2025, 1pm (eastern)

Since the FDA’s dietary supplement cGMP regulations (21 CFR Part 111) were published, specifications and testing have been consistently one of the most frequently cited FDA observations. Specifically, industry continues to face challenges in complying with the specification and testing requirements for dietary supplement components. This webinar will examine the requirements for specification establishment and testing for dietary ingredients and other ingredients. We will review the specific regulations, FDA’s interpretation of the regulation as demonstrated through enforcement, and practical ways to comply with the requirements.

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About the Presenters

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.