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(571) 447-5500
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 * About Us
   * Overview
   * Our Team
   * Associations
   * Cooperative Agreements
   * Work Opportunities
 * Services
   * Consulting
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   * 21 CFR Part 11
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Select Page
 * About Us
   * Overview
   * Our Team
   * Associations
   * Cooperative Agreements
   * Work Opportunities
 * Services
   * Consulting
   * Auditing
   * Training
   * Submissions
   * GRAS, FCNs and Food Additive Petitions
   * 483 and Warning Letter Remediation
   * Product Development and Labeling
   * US Agent and Imports
   * Recall Assistance
   * Expert Witness and Legal Support
   * Due Diligence, M&A Insurance Support
   * 21 CFR Part 11
 * Industries
   * Foods
     * Food Safety (Food Safety Modernization Act)
     * Food Submissions
     * Food Labeling and Claims
     * USDA
   * Dietary Supplements
   * Cosmetics
   * Pharmaceuticals
   * Medical Devices
   * Tobacco
   * Cannabis, Hemp & CBD
   * Veterinary
 * Events
   * Trainings
   * Webinars
   * Tradeshows and Conferences
 * Resources
   * On-Demand Webinars
   * Videos
   * Service Information Sheets
   * FDA News
   * White Papers
   * Glossary of Terms
 * EAS Blog
 * Shop
 * Contact Us
 *  




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   •
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SEMINARS


COSMETIC SAFETY SUBSTANTIATION

Presented by Paula Brock, Ph.D., MCSI, EAS Senior Regulatory ConsultantJuly 25,
2024 11:00am - 1:00pm (Eastern)The Modernization of Cosmetics Regulations Act of
2022 (MoCRA) became effective in December 2023 and includes a requirement for
safety substantiation. MoCRA...

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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...

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LATEST NEWS


PRODUCT CLAIM SUBSTANTIATION

By Jay Ansell, EAS Independent ConsultantSubstantiating a product claim is
required by U.S. law and can help brands avoid regulatory action or provide an
effective defense in litigation. For...

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DRUG AND DEVICE MAY 2024

Final reminder that OMUFA facility user fees are due 1 June 2024. Per MoCRA,
responsible persons are required to submit any serious adverse event reports to
the FDA within 15 business days of...

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QUALITY MANAGEMENT SYSTEM (QMS) DOCUMENTATION

By Jeff VanderHoek, EAS Independent ConsultantThe design and manufacturing of
medical devices requires a high level of quality and reliability to ensure
patient safety and regulatory compliance. The...

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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.

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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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