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
Drug OTC GMPs and Labeling
A Five-Part Virtual Series Presented by Bryan Coleman, Senior Director of Pharmaceuticals and Medical Devices; Victoria Pankovich, EAS Regulatory Specialist; Norma Skolnik, EAS Independent Consultant; and Bruce Elsner, EAS Independent Consultant. February 2, 9, 16,...
Webinars
CBD and Hemp Manufacturing and Safety
A Three-Part Webinar Series October 20, 27 & November 4, 2021, each at 1pm ETEAS Consulting Group, leaders in FDA, USDA and state regulatory issues, is hosting a three-part series on CBD and hemp regulations. From a higher-level look at where federal regulations...
On Demand Webinars
Foreign Supplier Verification Program Failures – FDA’s Number One FSMA Citation
Presented by EAS Independent Consultant, Carlos Ortiz. Did you know that FSMA requires an established FSVP that places the onus of compliance verification for all aspects of FSMA on the importers? Failure to meet FSVP requirements can jeopardize any food or food...
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
FSNS Announcement
We are excited to announce that Certified Group has signed an agreement to merge with Food Safety Net Services (FSNS), a leading provider of laboratory testing services for customers in the food...
Drug and Device Corner September 2021
As part of the 2020 CARES Act, section 506J has been added to the FD&C Act. This section requires manufacturers of certain medical devices to report any interruption or permanent discontinuance...
Brad Douglass Blogs for NCIA on GRAS for Cannabinoids
EAS dietary supplement, hemp, and CBD expert, Brad Douglass, Ph.D. published a blog for the National Cannabis Industry Association (NCIA) on GRAS as an option for cannabinoid food additive...
Drug OTC GMPs and Labeling
A Five-Part Virtual Series Presented by Bryan Coleman, Senior Director of Pharmaceuticals and Medical Devices; Victoria Pankovich, EAS Regulatory Specialist; Norma Skolnik, EAS Independent...
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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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