The Experts in FDA 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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Seminars
Acidified Foods (AF) & Low-Acid Canned Foods (LACF) Virtual Training
Two EAS Seminars with Better Process Control School (BPCS) Official ContentInstructed by Omar Oyarzabal, Ph.D. EAS Independent Consultant and FDA-Recognized Instructor for BPCS Acidified Foods (AF) November 1, 3, 8 & 10, 2021 12-4 eastern each day Low-Acid Canned...
Webinars
Validación de limpieza CIP
Presentado por Bernardo Clavijo August 10, 2021 at 1pm eastern. Para dar cumplimiento a los requisitos legales y normativos vigentes, es importante realizar la validación de las medidas de control de la inocuidad, entre las cuales está la limpieza y desinfección de...
On Demand Webinars
Cleaning Validation – Your GMPs Depend on It
Presented by Joe McGuinness, EAS Independent Consultant. For FDA to require that equipment be clean prior to use is nothing new, with the main rationale to prevent contamination or adulteration of drug products. Per FDA’s current Good Manufacturing Practices (cGMPs),...
COVID-19 Updates
Food Industry Control and Protection Against COVID-19
The COVID 19 Pandemic has forced the food industry to alter some of its operations in order to maintain a safe environment for its employees and customers. Urgent attention must be given to ensure compliance with measures that protect food workers from …
EAS Update: FDA Announces Resumption of Domestic Inspections with New Risk Assessment System
FDA announced on July 10, 2020 its intention to resume prioritized domestic inspections beginning the week of July 20, 2020. The locations of inspections will be based on the COVID-19 virus’...
Food Labeling Challenges in a Pandemic
Under normal circumstances, food producers have many plates to spin in order to comply with food regulations, including food labeling requirements. Most especially, in order to assure accurate food ingredient, allergen and nutrition labeling, manufacturers must be certain they possess the most recent …
Latest News
Tara Couch Discusses FDA Enforcement of Dietary Supplements in RAPS Regulatory Focus
The pandemic has resulted in an increase in the number of misbranded dietary supplements. As a result, FDA is using updated, alternative, and remote enforcement tools to ensure compliance. Tara...
Do you Make Good, Clean and Healthy Claims on Your Product Labels?
You may be misrepresenting your products by making claims such as good, clean and healthy. FDA has clearly defined definitions for some claims and deciding which to make to market your products can...
Cleaning Validation – Your GMPs Depend on It
Presented by Joe McGuinness, EAS Independent Consultant. For FDA to require that equipment be clean prior to use is nothing new, with the main rationale to prevent contamination or adulteration of...
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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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