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Learn From Our Library of 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.

Food Allergens and the FDA

Food Allergens and the FDA

An EAS and Food Safety News Complimentary Webinar. What’s Happening. Presented by Steve Gendel, EAS Independent Consultant. As we approach 20 years since the passage of the Food Allergen Control and Consumer Protection Act of 2004 (FALCPA), industry and the FDA continue to struggle with many...

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Food Fraud Mitigations and Testing

Food Fraud Mitigations and Testing

EAS and Food Safety News Complimentary WebinarPresented by EAS Senior Directors,Tim Lombardo, Food Consulting Services andMaged Sharaf, Ph.D., Labeling, Cannabis and Claims Services. April 20, 2022, at 1pm easternFood Fraud is a global challenge, costing billions to the food industry and consumers...

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The 12-Steps of Operational Efficiency

The 12-Steps of Operational Efficiency

How Aligning of Operations and Quality Assurance Can Drive Down Costs While Improving Efficiency. Presented by Mike Hughes and Steve Cammarn, Ph.D., EAS Independent Consultants. Operations and Quality Assurance departments often operate in opposition. Their different goals lead to different...

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Medical Device Product Risk Management

Medical Device Product Risk Management

Presented by John Lincoln, EAS Independent Consultant. Both the U.S. FDA and the EU's MDR require product risk management as part of virtually all regulatory compliance efforts. Companies must be proactive in reducing product risk while increasing user benefits though many are still not developing...

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Validación de limpieza CIP

Validación de limpieza CIP

Presentado por Bernardo Clavijo. Para dar cumplimiento a los requisitos legales y normativos vigentes, es importante realizar la validación de las medidas de control de la inocuidad, entre las cuales está la limpieza y desinfección de las superficies de contacto. ¿Qué significa esto para su...

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Hygiene Improvement, Monitoring & Tracking

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 …

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Selecting and Submitting an ANDA Application

Selecting and Submitting an ANDA Application

The FDA Generic Drug User Fees Amendment (GDUFA) has entered a relatively matured stage with applicants of Abbreviated New Drug Applications (ANDAs) experiencing a timely review and communications regarding their submissions packet, as well as increasing approval numbers. However, until …

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Retail Food Safety in a Post-Pandemic World

Retail Food Safety in a Post-Pandemic World

The Retail Food Industry is finally beginning to see an opening as many areas of the country are experiencing decreasing cases of COVID-19, meaning businesses can begin to safely scale up. But what does that mean and how can the retail food industry ensure safe operations in this new normal? Do you understand …

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Codex Opportunities for Food Manufacturers

Codex Opportunities for Food Manufacturers

Can Codex food standards and various food safety, hygiene guidelines and codes of practice positively impact domestic food manufacturers that do not export? The short answer is “YES!” Codex provides a transparent international platform for food safety and hygiene as well as manufacturing practices, food …

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Navigating CBP and Prior Notice of FDA’s Imported Products

As the pace of FDA regulated products increases, companies importing food, dietary supplements, food additives, food and dietary ingredients to the United States must keep pace with changing regulations intended to ensure the safety of U.S. consumer and integrity of the food-based products being imported. FDA has historically seen an import rate increase of 5-10% in the last decade and in 2018, 31% of those were food products requiring prior notice.

Understanding how to navigate the FDA and US Customs import process, including how to utilize their programs to expedite the review of paperwork and shipments at the US ports of entry will be …

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Qualified Individuals – FDA’s Final Link in the Chain of Food Safety and Food Imports

The Food Safety Modernization Act, signed into law in 2011, includes an important provision for food importers under the Foreign Supplier Verification Program (FSVP) Final Rule. Namely, Part 1 Subpart L, Section §1.503 requires that importers of human and animal food enlist a Qualified Individual (QI) who has responsibility for developing a program and …

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Pharma’s Problems with Data Integrity

FDA takes data Integrity very seriously and their many Warning Letters and Import Alerts to dosage form and Active Pharmaceutical Ingredient (API) manufacturers in the past several years, indicate that validation is a consistent problem for the pharmaceutical industry. Data integrity, or lack thereof …

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The Role of Your US Agent

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 submissions such …

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Medical Device Quality Auditing

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 …

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