The Experts in FDA and USDA Regulatory Matters
EAS Consulting Group is a leading provider of regulatory compliance solutions to industries regulated by FDA, USDA, and supporting agencies. Our team of consultants provide expert guidance for all of your regulatory requirements.
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Our Services: Consulting • Submissions • Auditing • Training • Legal Support
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Seminars
Cosmetic Safety Substantiation
Presented by Paula Brock, Ph.D., MCSI, EAS Senior Regulatory ConsultantFebruary 22, 2024 1:00 - 3:00 (Eastern)The Modernization of Cosmetics Regulations Act of 2022 (MoCRA) became effective in December 2023 and includes a requirement for safety substantiation. MoCRA...
Webinars
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On Demand Webinars
Reassessment of EMPs
Reassessment of EMPs: Have You Identified the Correct Sampling Locations to Protect Your Product?An EAS Complimentary Webinar Presented by Rocelle Grabarek, EAS Independent ConsultantMarch 27, 2024 • 1pm (Eastern) 1.5 hoursMany of the environmental monitoring programs...
Latest News
Control of Cronobacter in Dairy Dryer and Packaging Rooms
By Beth Koenig, EAS Independent ConsultantWhat Is Cronobacter and Why Should We Be Concerned About It? Cronobacter, a genus of bacterial pathogens in the Enterobacteriacea family is of considerable...
FY2024 OMUFA User Fees Announced by FDA
FDA announced the fiscal year 2024 OTC-Monograph Drug User Fee rates in the Federal Register Vol 89, No. 62 published 29 March 2024. These fees cover FDA’s FY2024 which runs from October 2023...
FDA Issues Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements
Today, the U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.”...
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EAS – Your Dedicated Consultant for FSVP Services
EAS offers comprehensive services related to FSMA’s FSVP program for both foods and dietary supplements. We can even act as your Qualified Individual. For more information about our services, watch our short video.
Dietary Supplement Good Manufacturing Practice Compliance Short Course
The GMPs dictated in 21 CFR 111 have been in place for over a decade, but the FDA continues to issue numerous Warning Letters for a failure to comply with even the basic tenets of the regulation. EAS Consulting Group’s two-part short course covers the basics of working in a GMP environment including personal hygiene, sanitation, the use of SOPs, and Good Documentation Practices (GDPs). It also addresses the top 5 observations cited in FDA Warning Letters since 2010 which are Specifications, Master Manufacturing and Batch Production Records, Quality Unit responsibilities, Product Complaints, and Holding and Distribution Operations.
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