On-Demand Webinars

Foreign Supplier Verification Program – What Does it Mean for You? En Espanol Si usted exporta alimentos, ingredientes, empaques, suplementos o aditivos alimenticios hacia los Estados Unidos, su agente aduanal en los Estados Unidos, importador y clientes le pedirán proporcionar documentación para verificar que su empresa cumple con la Ley de Modernización de la Inocuidad […]

Foreign entities who operate in US FDA regulated industries must have an appointed US Agent before doing business and importing products into the US. US Agents act as an intermediary between the foreign company and FDA, assisting with two-way communication on requirements and questions such as establishment and facility registrations, product listings as well as […]

Presenter: EAS Independent Consultant – George Gary Calafactor Medical Device manufacturers understand the tight FDA regulations and legal obligations surrounding devices. From initial safety and effectiveness study design through Pre-Market Applications (PMAs), Pre-Market Notifications (PMN), registration, Good Manufacturing Practices (GMPs) through reporting of adverse events, every detail must be attended to in a thorough and […]

Do you understand the impact of the Food Safety Modernization Act (FSMA) on Acidified Foods (AF)? Do you understand the terms of AF regulations and the interplay with a modern, risk-based food safety plan? Is your food safety system for AF robust enough for an inspection by the Food and Drug Administration (FDA)? This webinar […]

EAS Webinar Series on GMP Compliance in Dietary Supplement Laboratories Back by popular demand – Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will discuss Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. This series, originally run in 2015, will discuss various aspects of regulatory compliance with 21 CFR […]

EAS Webinar Series on GMP Compliance in Dietary Supplement Laboratories Back by popular demand – Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will discuss Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. This series, originally run in 2015, will discuss various aspects of regulatory compliance with 21 CFR […]

EAS Webinar Series on GMP Compliance in Dietary Supplement Laboratories Back by popular demand – Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will discuss Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. This series, originally run in 2015, will discuss various aspects of regulatory compliance with 21 CFR […]

EAS Webinar Series on GMP Compliance in Dietary Supplement Laboratories Back by popular demand – Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will discuss Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. This series, originally run in 2015, will discuss various aspects of regulatory compliance with 21 CFR […]

While 2017 is a year for manufacturing facilities to augment their FSMA programs for US markets, 2018 will be a year to update their GFSI systems. Beginning in January SQF advances to Edition 8.0.  Learn more about these revisions and the impact on SQF 8.0 on facilities who are, or plan to be, certified by […]

If you export food, food ingredients, food packaging, dietary supplements or food additives to the United States, your U.S. Importer will soon require that you provide documentation verifying that your company is compliant with the Food Safety Modernization Act (FSMA) regulations from the U.S. Food and Drug Administration (FDA). This could include compliance with a […]

EAS Client – Exclusive Webinar The US Food and Drug Administration’s will require all importers, starting at the end of May 2017 to have on hand for FDA review, significant new food safety documentation at their US office(s) for all foreign suppliers of food, food ingredients, and food additives. The FDA’s “Foreign Supplier Verification Program […]

One of the most fundamental concepts in the dietary supplement regulation dictated in 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, is the role of the Quality Unit (QU). The QU is responsible for reviewing and approving all controlled processes and documentation; as well as making all disposition […]

EAS Senior Advisor for Quality and Compliance, Mr. Robert Fish, will present a webinar on How to Respond to FDA 483s and Warning Letters. He will discuss the correct and incorrect way to prepare these responses with emphasis on the FDA’s expectations. He will also explain why companies may receive an FDA 483 and how […]

With FDA inspections becoming more frequent, particularly in the dietary supplement world, it is imperative that companies familiarize themselves with how to host and manage such an inspection. We say “manage an FDA inspection” because the more knowledge a company has the better able it will be to make the inspection process move smoothly in […]

This FSMA webinar will explore FDA’s anticipated enforcement strategy following finalization of the Hazard Analysis and Risk-based Preventive Control (HARPC) regulations for manufactured foods. The final rule will require that each food facility identify a “Qualified Individual” to conduct a multi-factor hazard analysis, then design and implement a written plan to control significant hazards. The […]

The widespread use of social media has had an impact on how we interact in our personal and professional relationships. It is also having a profound effect on businesses and their relationships with customers. For those of us in FDA-regulated industries, there are implications for marketing strategies and what companies are allowed to say. While […]