EAS Blog
EAS Independent Consultants and staff provide in-depth regulatory expertise and authoritative reporting on a variety of compliance requirements for industries that EAS serves. Our experts break down complicated topics into easily understandable summaries and analysis. Subscribe to our newsletter and receive these monthly updates directly in your in-box.
US FDA Proposed Traceability Rule – Overview
Presented by Allen Sayler, Senior Director, Food Consulting ServicesDecember 2, 2020 11am-12pm easternFDA’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...
New Ingredients in Pet Food Formulation: Not as easy as creating a product with a few trending ingredients
By Carolyn KennedyEveryone is looking for the next best thing when it comes to pet food. Many companies have tried to introduce new ingredients. Often, the new ingredients in pet foods mirror the trending ingredients in human food. There has been an influx of CBD and hemp treats in pet foods, with...
Equipment Sanitation and Dietary Supplements – Which cGMPs Apply to Me?
As a dietary supplement firm, and a subcategory of foods, how do you decide which cGMPs to follow? The answer is determined by what specifically you produce – dietary supplements or dietary ingredients. Once that is understood, the cGMP operational requirements, particularly around equipment...
GMPs for Hemp and CBD?
Developing solid GMP protocols is essential for firms operating in the hemp and CBD space. Read EAS independent consultant Charlotte Peyton’s blog published on the National Cannabis Business Industry (NCIA)’s website. Join EAS for our upcoming EAS short course on developing quality systems for CBD...
Drug and Device Corner September 2020
EAS would like to remind all eNews readers of the importance of an appointed U.S. Agent. The FDA recently deactivated the FDA registrations of 340 foreign establishments that failed to identify a U.S. Agent as required by FDA’s regulations. As we head into the FDA registration renewal period,...
EAS Becomes GRMA Trusted Partner
The Global Retailer and Manufacturer Alliance (GRMA) recently confirmed EAS as a Trusted Consulting Partner for their member organizations. As a Trusted Partner EAS assists GRMA member suppliers and vendors with regulatory operational support. Acceptance into the Trusted Partner program is through...
House Vote on Legalization of Marijuana Delayed
Of interest to the hemp, CBD and cannabis industries, the US House Democratic leaders have decided to postpone voting on legislation to decriminalize marijuana at the federal level until after the November 3, 2020 election. EAS team of consultants, under leadership of Senior Director Tara Lin...
Food Legislation in the EU – An Introduction
An EAS Short CoursePresented by Michael Hickey, EAS independent consultant January 12-13, 202111am - 12:30pm eastern each dayIf you sell food products in the EU, understanding EU Food legislation is critical to success. Join EAS Consulting Group’s expert in EU Food regulations, Michael Hickey for...
California Proposition 65 and the Food Industry
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 …
Process Validation for OTC Liquids and Topical Products
Presented by EAS Independent Consultant, Miguel Montalvo December 9-10, 2020 12:00–3:00pm EasternIf you manufacture OTC liquids, such as hand sanitizers, and other topical products, an effective Process Validation Program is an FDA requirement. Do you have a robust Process Validation Program at...
Preparing for a PMTA Pre-Approval Inspection
Presented by Tara Lin Couch, Ph.D., EAS Senior Director for Dietary Supplement and Tobacco Services The Family Smoking Prevention and Tobacco Control Act referred to as the Tobacco Control Act (TCA), signed into law on June 22, 2009 includes a number of …
Good Auditing Practices, Making the Most of Your Internal Review – EAS Short Course
Regular and formal internal audits provide a clear, unbiased view of your facility operations and uncover challenges that must be addressed. No matter your FDA regulated industry, having a formal, thorough and documented audit plan will streamline your audit processes …
Developing Quality Systems for the CBD and Hemp Industries – EAS Short Course
As states begin to regulate legalized CBD and hemp, the concern of how Good Manufacturing Practices (GMPs) apply to these unique industries cannot be understated. While regulations vary from state to state the quality systems under which products are grown …
Hygiene Improvement, Monitoring & Tracking
While the “new norm” for food manufacturing hygienic practices is rapidly evolving, an intense focus on proactive assurance of food and employee safety is the top industry priority. With increased focus on hygienic practices comes an increased requirement to data …
Understanding and Mitigating Risks of Emerging Pathogens
The food industry has a history of testing for Enterobacteriaceae, coliforms and/or E. coli as indicator microorganisms. Since 2009 there were 40 outbreaks in the United States of pathogenic E. coli such as Shiga toxin-producing E. coli (STEC) associated with leafy greens…
Did you Know? EAS Assists with California Prop 65 Requirements
Proposition 65 requires specific warnings be applied to products sold in California that contain any one of the ~900 chemicals on the Proposition 65 list, whereby use of the product results in consumer exposure to those chemicals above Safe Harbor Levels. EAS is a regulatory partner helping firms...
Maintaining Compliance through Virtual Audits
When the phone rings at EAS Consulting Group lately it is very often someone seeking assistance with Good Manufacturing Practices. While COVID-19 has caused major disruptions to global supply chains and manufacturing capabilities, FDA regulated industries forged ahead…
Drug and Device Corner August 2020
The FDA recently published a laboratory testing method to assess the quality of finished hand sanitizer products. This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. Due to the flood in the market of...
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 …
Dairy Processing 101
A Virtual Training Presented by EAS Consulting Group October 15, 22, 29 and November 5, 2020 12:00pm-4:00pm eastern each day The US dairy processing industry is facing regulatory, technology, competitive and economic pressures that are almost overwhelming. Keeping current on all these...