EAS Consulting Group, LLC

Join us for a complimentary EAS Consulting Group, LLC webinar, "Risk-Based Approach to CSV, 21 CFR Part 11, and FDA Compliance," hosted by Carolyn Troiano on November 8. This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do, and a key element is a thorough risk assessment. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement, making it critical to continue assessing risk as changes are made. We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered. More specifically, we will discuss how FDA’s requirements for ER/ES may be met through validation testing. 21 CFR Part 11, the FDA’s guidance from 1997 on ER/ES requires specific criteria to be defined and met, as demonstrated through appropriate testing, in order to prove the functionality meets the letter of the law. Register Today - https://hubs.ly/Q02VlwhL0

Human Food Program (HFP) FY 2025 Priority Deliverables The FDA is responsible for regulating 80% of the U.S. food supply, with the Human Foods Program (HFP) overseeing all activities related to food safety and nutrition. The FDA launched the HFP as part of a broader agency reorganization on October 1, 2024. The HFP’s design streamlines operations and unifies all FDA food functions, personnel, and resources that are programmatic in nature under the leadership of the Deputy Commissioner for Human Foods. The HFP’s vision is to ensure that food serves as a vehicle for wellness, and our day-to-day activities support our mission to protect and promote the health and wellness of all people through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure chemicals in food are safe. In FY 2025, we will develop a multi-year strategic plan to advance the HFP’s vision and mission. While that work is underway, we have developed this document to highlight the key deliverables that we will accomplish in FY 2025 within the context of our program’s design and responsibilities [https://hubs.ly/Q02WYPDX0]. It is also intended to demonstrate the HFP’s commitment to transparency and accountability as we continuously evolve to meet the demands of constantly changing public health and regulatory challenges. We will provide updates on our FY 2025 priority deliverables as we make progress throughout the year. Human Foods Program: Designed with Public Health and Organizational Effectiveness in Mind The HFP is designed to facilitate a consistent, systematic, and intentional risk management approach to our regulatory responsibilities. To meet our public health mission and vision more effectively and efficiently, we centralized our risk management activities into three main areas: 🔹 Microbiological Food Safety: Advancing strategies to prevent pathogen-related foodborne illness in close collaboration with other regulatory agencies, states, industry, and other stakeholders. [https://hubs.ly/Q02WYCw-0] 🔹 Food Chemical Safety: Ensuring that exposure to chemicals, including both additives and contaminants, that occur in foods is safe, advancing dietary supplement safety, and supporting and effectively regulating food ingredient innovation. [https://hubs.ly/Q02WYCxZ0] 🔹 Nutrition: Elevating and empowering action on nutrition science, policy, and initiatives to help reduce the burden of diet-related chronic diseases, improve health equity, and ensure the nutritional adequacy and safety of infant formula. [https://hubs.ly/Q02WYKtZ0] Read Full FDA Post - https://hubs.ly/Q02WYBwn0

The U.S. Food and Drug Administration (FDA) today has published the Supplement to the 2022 Food Code [https://hubs.ly/Q02WQng20]. The Supplement updates the 2022 Food Code [https://hubs.ly/Q02WQDD_0] with recommendations made by regulatory officials, industry, academia, and consumers at the 2023 Biennial Meeting of the Conference for Food Protection. The Food Code and its Supplement provide government and industry with practical, science-based controls for reducing the risk of foodborne illness in retail and foodservice establishments of all types. The Food Code and the Supplement are joint projects by the FDA, the Centers for Disease Control and Prevention, and the United States Department of Agriculture (USDA) – Food Safety and Inspection Service (FSIS). Read Some highlights in the Supplement to the 2022 Food Code include: https://hubs.ly/Q02WQnRC0 The next complete revision of the Food Code will be published in 2026. For additional information, visit Retail Food Protection [https://hubs.ly/Q02WQBFF0].  

Interested in doing business of health products in Canada? This free webinar presented by Paula Brock, provides an overview of the Canadian regulation on natural health products and how EAS Consulting Group can assist companies with the diverse requirements of Health Canada. Register today - https://hubs.ly/Q02Vm5dr0

Jeb Hunter, a Senior Consultant at EAS Consulting Group, LLC, recently shared his insights in a Pharmacy Practice News article. He offers valuable advice on gearing up for your upcoming inspection. 📰 Read full article - https://hubs.ly/Q02W8t_V0

Join us for a complimentary EAS Consulting Group, LLC webinar, "Risk-Based Approach to CSV, 21 CFR Part 11, and FDA Compliance," hosted by Carolyn Troiano on November 8. We'll dive into how you can meet the FDA's requirements for electronic records and electronic signatures (ER/ES) through thorough validation testing. The 21 CFR Part 11 guidance, set by the FDA in 1997, lays out specific criteria that must be clearly defined and achieved. By conducting the right tests, you can ensure your system's functionality aligns perfectly with these regulations. Register Today - https://hubs.ly/Q02VlRgV0

EAS Consulting Group, with our vast expertise in assisting food and supplement firms in all manners of FDA compliance is offering a food and dietary supplement labeling compliance virtual seminar. Taking place over three days, from 11am each day, our experts will walk you through the requirements of a label, what information is required and in what order, how to determine amounts and how to list ingredients. You’ll learn the complex set of labeling rules and get answers to your most challenging questions. Register today - https://lnkd.in/eGw5PjHM

Join us in Las Vegas at this year's SupplySide West show, where top specialists from the Certified Group of companies—featuring EAS Consulting Group, LLC, Certified Laboratories, Inc., and Food Safety Net Services (FSNS)—a world-renowned leader in FDA regulatory compliance and testing, will be present. Stop by booth #3131 and say hello! 👋 We’d love to talk about how our services can support your business. 🔸 Meet one-on-one with our dietary supplement experts, business development managers, and consultants. 🔸 Explore our dietary supplement lab testing solutions and discuss your product safety testing needs, including microbiology, analytical chemistry, and custom research projects. 🔸 Learn about our regulatory consulting services, including label reviews, claims reviews, and process audits.

In order to increase the sales opportunities of German companies on the US market and to avoid costly subsequent label checks and corrections, the Hanover Chamber of Industry and Commerce, with the support of the Federal Ministry of Food and Agriculture, has designed an online workshop to help companies design their own labels for food supplements in line with the US market. Presented in German by Gisela Leon, EAS Consulting Group, LLC Independent Regulatory Consultant, from the USA, but as a native German speaker and with more than 17 years of experience in reviewing German labels of food, nutritional supplements and cosmetics for the US market. This will take place on November 11th and 12th from 12:30 p.m. to 5:00 p.m. (CET) with a focus on the mandatory labeling for nutritional supplements according to FDA regulations. The third and final day (November 13th, 12:30 p.m. to 6:00 p.m. CET) is reserved for the claims. Further details can be found on the IHK Hannover event calendar https://hubs.ly/Q02VLMJ10. Since the workshop offers plenty of space for examples and clarification of practical questions, the number of participants is limited. Registration should be made by October 28th 2024.

A recent study analyzed FDA food product recall data from 2002–2023, drawing conclusions from more than 35,000 product recalls. 👉 MORE: https://lnkd.in/gmjbXXE6 #foodsafety #foodindustry #foodrecalls #FDA