On-Demand Webinars

The detailed technical knowledge of EAS Senior Directors and Independent Consultants sets us apart from the competition and EAS frequently offers webinars in a public forum to provide a regulatory overview of hot topics that enable greater industry understanding. These public webinars are also available on-demand, here on the EAS website. We hope that you find them informative and welcome any questions or comments.

Temporary Marketing Permits – Opportunity and Pitfalls of the Specialized FDA Application

August 23, 2018

Food Standards are an important component of FDA’s oversight, ensuring honesty and fairness to the consumer through requirements that provide for the basic nature of a standardized food to be uniform in terms of its characteristics as well as the ingredients that it must or may contain, (i.e., mandatory and optional ingredients. But what happens […]

Preparing for Foreign FDA Inspections

August 22, 2018

Have you ever wondered why your foreign suppliers: API, intermediates, food ingredients, etc. are suddenly in trouble with regulatory authorities? Did they just go astray or is your auditing program not performing as designed? Actually, there are several things at play. EAS Independent Consultant, Peter Saxon, will shed some light on reasons FDA inspections can […]

Quality Systems for the Cannabis Industry – Preparing for State GMP Regulations

August 15, 2018

Presented by:Tara Lin Couch, Ph.D.Senior Director, Dietary Supplement and Tobacco Services As states begin to regulate legalized cannabis, the concern of how Good Manufacturing Practices (GMPs) apply to this unique industry cannot be understated. While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that […]

Conferencia web de EAS: Programa de verificación de proveedores extranjeros – ¿qué significa para usted?

June 6, 2018

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 […]

The Role of Your US Agent

February 27, 2018

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 […]

Medical Device Quality Auditing

January 29, 2018

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 […]

Unraveling The Impact of FSMA On Acidified Food Regulations

December 18, 2017

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 […]

How to Select and Qualify a Contract Laboratory

November 21, 2017

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 […]

What is a Scientifically Valid Method?

October 31, 2017

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 […]

Using Analytical Instrumentation Appropriately

October 20, 2017

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 […]

21 CFR 111 GMP Laboratory Overview

October 12, 2017

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 […]

Key Changes in SQF 8.0

September 13, 2017

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 […]

Foreign Supplier Verification Program – What Does It Mean For Your Business

June 21, 2017

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 […]

Foreign Supplier Verification Program, FSMA’s Next Big Challenge

April 18, 2017

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 […]

Quality Agreements in the Complex World of Dietary Supplements

June 10, 2016

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 […]

How to Successfully Respond to FDA 483s and Warning Letters

June 6, 2016

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 […]

Managing FDA Inspections

October 2, 2015

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 […]

FDA Strategies to Implement & Enforce the Food Safety Modernization Act

August 15, 2015

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 […]

Regulatory Compliance Strategies for Marketing Dietary Supplements on Social Media

June 18, 2015

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 […]