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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Dietary Supplement GMP Compliance Virtual Seminar
February 2, 4, 9 & 11, 2021 • Virtual Event
Enhance your understanding of compliance requirements under 21 CFR 111, responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved with the testing, quality control and distribution of supplements.
US FDA Proposed Traceability Rule – Overview
December 2, 2020
FDA’s proposed rule “Requirements for Additional Traceability Records for Certain Foods” mandates traceability recordkeeping requirements for certain foods such as cheeses, shell eggs, some types of fish and produce. When finalized, the Traceability Regulation will be the final component of FSMA and a key component of the FDA “New Era of Smarter Food Safety Blueprint,” implementing Section 204(d) of the FDA Food Safety Modernization Act (FSMA).
What does this proposed rule indicate and how can you begin preparing for this food safety blueprint?
Join EAS Senior Director for Food Consulting Services, Allen Sayler, for a deep dive into the proposed requirements and what they could mean for you.
Begin strengthening your record-keeping and traceability protocols to pave the way for faster identification of contaminated products and foodborne illnesses sources.
California Proposition 65 and the Food Industry
Presented by EAS Independent Consultant Tom Jonaitis
Proposition 65 is a statute that all companies selling products into California must comply with by providing warnings if their products contain certain chemicals that result in consumer exposure above a certain daily threshold. Failure to comply with the stringent requirements of Prop 65, which are above and beyond the requirements of any other federal or state safety/regulatory requirements, can result in costly enforcement action. The food and dietary supplement industries have been frequently targeted for alleged violations, and industry as a whole pays out tens of millions of dollars each year to plaintiff lawyers finding non-compliant products. EAS Independent Consultant, Tom Jonaitis, will provide key insights into the compliance and enforcement trends, important regulatory changes/case studies that highlight compliance issues, and practical guidance on how to ensure products are compliant.
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 …
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’...
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 …
EAS Complimentary WebinarPresented by Ramakrishnan Narasimhan, EAS Independent Consultant February 23, 2021 1pm easternThe Canadian Food Inspection Agency (CFIA) is responsible for the safety of...
Senior Director Allen Sayler has received the Award of Excellence by the Brussels-based IDF for outstanding contributions to their programs. Allen is an internationally recognized expert in dairy...
Recently Published Guidance Documents CDER Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment This guidance is intended to assist sponsors in developing drugs for...
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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 tenants 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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