EAS Consulting Group and National Restaurant Association Present: Proactive Food Safety Using Active Managerial Controls

January 28, 2020, at 2 PM Eastern

Presented by Charles Otto, EAS Independent Consultant and former Environmental Health Officer and Deputy Chief at the Centers for Disease Control and Prevention (CDC)

(registrations for this complimentary webinar are taken through the National Restaurant Association – registration coming soon)

While the diligent food safety manager assumes their routine Food Code compliance procedures are sufficient to protect against the introduction of pathogens at their retail establishment, but are they? 

Active Managerial Control (AMC) is a preventive food safety management system (FSMS) that can prevent the risk of foodborne illness through targeted standards, employee engagement, and continuing proactive appraisal. Once issues are identified by self-assessment, quick reaction can facilitate mitigation of those risks before they become a problem for consumers.

Learn how to design and implement AMC risk-based policies, training, and verification procedures for preemptive risk reduction. Explore the details of successful AMC development and implementation with coverage of resources to assist small to large operations. Join EAS Independent Consultant, Charles Otto, for an in-depth look at this crucial safety protocol for retail food establishments and ensure your FSMS is robust and your customers are safe.

In this webinar you will:

  • Understand how AMCs enhance Food Code compliance procedures
  • Learn how to design and implement AMC risk-based policies, training and verification procedures
  • Explore the details of successful AMC development and implementation 

About the Presenter:

EAS Consulting Group’s independent consultant, Charles Otto, is a former Environmental Health Officer and Deputy Chief at the CDC where he provided guidance on all aspects of environmental health to the CDC Vessel Sanitation Program staff, member cruise lines, shipyards, and other global collaborators for the prevention of environmentally-related illnesses. He has worked at FDA as the Assistant Director in the Division of Cooperative Programs as well as the Retail Food Protection Branch where he developed national Hazard Analysis Critical Control Point (HACCP) implementation strategies for retail food protection, interstate travel programs, milk safety, and shellfish sanitation programs and furnished comprehensive field training on proper interpretation and implementation of the model food code standardization exercises conducted in every region of the U.S.

About EAS Consulting Group:

EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. Our prime focus is to assist domestic and foreign pharmaceuticalmedical devicetobaccofooddietary supplementcosmetic and biologics firms comply with applicable laws and regulations. EAS is staffed with former FDA compliance and inspection officials and industry executives and is assisted by an extensive network of independent consultants with many years of FDA and industry experience.

Headquartered in Alexandria, VA with consultants and auditors located strategically throughout North and South America, Europe, and various Pacific Rim counties, EAS Consulting Group is a sought-after expert in regulatory matters, assisting firms with highly technical submissions such as GRAS, DMF, NDI, ANDA, 510(k) and others, as well as the development of quality systems, label reviews, structure-function claims, GMP audits, and US Agent assistance and more. In addition, EAS assists clients with remediation strategies and responding to Form 483’s, Lists of Observations, Warning Letters, and other FDA communications. EAS experts are often asked to serve as expert witnesses and are routinely asked to speak at worldwide events on technical regulatory issues. EAS is proud to have a solid reputation in the industry as the leading consulting and training firm for FDA regulatory matters. www.easconsultinggroup.com

About the National Restaurant Association

Founded in 1919, the National Restaurant Association is the leading business association for the restaurant industry, which comprises 1 million restaurant and foodservice outlets and a workforce of 15.3 million employees. We represent the industry in Washington, D.C., and advocate on its behalf. We sponsor the industry’s largest trade show (National Restaurant Association Show May 16-19, 2020, in Chicago); leading food safety training and certification program (ServSafe); unique career-building high school program (the NRAEF’s ProStart). For more information, visit Restaurant.org and find us on Twitter @WeRRestaurantsFacebook and YouTube.

Dietary Supplements and FSMA Compliance – Fallacy or Fact?

Tara Lin Couch, Ph.D. & Allen Sayler

In 1994 the Dietary Supplement Health and Education Act (DSHEA) created a new, legal class of products, called “Dietary Supplements”, which are regulated by the FDA as a subcategory of foods. Since DHSEA, the Food Safety Modernization Act (FSMA) of 2011 was passed, and as a category of foods, dietary supplements are now subject to seven major regulations to support enforcement of FSMA.

One of the most important of these regulations being 21 CFR 117, Current Good Manufacturing Practice (cGMP) and Hazard Analysis and Risk-Based Preventative Controls for Human Food (PCHF), which requires, among other things, that a Preventive Controls Qualified Individual (PCQI) develop a food safety plan. Another FSMA requirement is the need for a Foreign Supplier Verification Program (FSVP) when dietary ingredients and dietary supplements are sourced internationally, (estimated to be over half of all dietary supplement ingredients). Unfortunately, the dietary supplement industry is plagued by lack of compliance with these critical FSMA requirements and the FDA is beginning to crack down on firms with increased enforcement actions.

How does the dietary supplement industry, including raw material manufacturers and dietary ingredient suppliers, dietary supplement manufacturers, and dietary supplement brand owners referred to as Own Label Distributors (OLDs) avoid enforcement actions? What aspects of FSMA’s Preventive Controls for Human Foods, 21 CFR 117, apply to dietary supplements and what about other FSMA responsibilities like FSVP?

Join EAS Consulting Group’s FSMA and Dietary Supplement experts Tara Lin Couch, Ph.D., Senior Director for Dietary Supplement and Tobacco Services and Allen Sayler, Senior Director for Food Consulting Services for an overview of the FSMA regulation and a deeper dive into those aspects which specifically apply to dietary supplements. Learn the crucial steps to compliance, including what must be included in a dietary supplement written and documented program as well as the FDA FSMA FSVP requirements applicable to dietary ingredients and dietary supplements sourced from outside the US.

Dietary Supplement OLDs, manufacturers and dietary ingredient suppliers all have an obligation to protect public safety and ensure compliance with all the applicable regulations. Understanding these FSMA requirements and their role in the supply-chain are key to ensuring compliance.

About the Presenters

Tara Lin Couch, Ph.D.
Senior Director of Dietary Supplement and Tobacco Services

Dr. Tara Lin Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in pharmaceutical, dietary supplement and tobacco manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a Senior Director for EAS Consulting Group, Dr. Couch has assisted numerous companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.

Allen Sayler
Senior Director of Food Consulting Services

Allen Sayler is the Senior Director for Food Consulting Services at EAS. Mr. Sayler had been an independent consultant for EAS since 2012 and promoted in 2017. His expertise in the areas of food processing, particularly in the area of dairy processing, infant formula, bakery products, food additives, botanical products and food packaging as well as GSFI Third-Party Certification programs such as Safe Quality Foods (SQF) has been of great value to EAS clients. Allen has spent more than 30 years as a food processing and regulatory expert, with half of the time serving the industry and the other have as a state and federal government employee. For twelve of those years, he served as vice president of regulatory affairs and international standards at the International Dairy Foods Association. Prior to that, his government career included working on dairy standards and grading programs at the Dairy Division of USDA’s Agricultural Marketing Service, FDA’s Milk Safety Branch – including a stint as acting chief of the branch and ten years as Assistant Dairy Commissioner for the North Dakota Department of Agriculture. Prior to joining EAS full time, he was a Managing Partner of the Center for Food Safety & Regulatory Solutions. His international experience includes representing the US food processing industry at the Codex Committees on Food Additives, Food Labeling, Food Hygiene and Milk & Milk Products.

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Cutting Edge Methods for Detecting Food Fraud

March 4, 2020, at 1 PM Eastern

Presented by Mehrdad Tajkarimi, Ph.D., EAS Independent Consultant

The challenge of detecting Food Fraud has never been greater nor the economic loss to food manufacturers, importers, retailers and consumers. In the recent past, we have had to rely on the integrity of the supply chain, person to person relationships and trained sensory staff to try and identify food fraud. The supply chain has become long and complicated, person-to-person relationships are not as strong as in the past and the sophistication of those making and selling fraudulent food can fool even a well-trained sensory specialist.

Thankfully the ongoing development of reliable and repeatable laboratory testing methods for analyzing and detecting fraudulent foods is advancing to the point where food fraud may be detectable at all levels of the supply chain. As the detection technologies advance, this technology is also becoming more readily available and less costly with results available in minutes or hours versus days and weeks.

Join EAS Independent Consultant Dr. Mehrdad Tajkarimi for a deep dive into the latest and greatest technologies in food fraud detection and their applications.

This is the last of the EAS series of webinars on Food Fraud so join us on March 4, 2020, at 1 pm eastern to expand your knowledge base and learn of the food fraud detection tools that can protect your company and customers from the increasing common practices of misrepresenting foods for economic gain.

About the Presenter

EAS independent consultant, Mehrdad Tajkarimi, Ph.D. is an expert in national and international food safety regulations, warehouse and wholesale manufacturing, dairy, grain, poultry and retail industries, HACCP, food defense, ISO 22000, BRC. He assists clients with organic requirements, Food Safety Modernization Act (FSMA), as well as in natural food preservatives and packaging, foodborne pathogenic and spoilage microorganisms characteristics, SPC and shelf-life studies.

Codex Opportunities for Food Manufacturers

January 16, 2020, at 1 PM Eastern

Presented by Richard White and Allen Sayler

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 standards (ranging from dairy products to seafood to pasta), acceptable and unacceptable food additives specific to every food sector, contaminant levels in all foods, etc.  Understanding Codex and how to make use of Codex standards, guidelines and codes of practice can benefit every food manufacturing business, whether food products are exported or not.   

As you focus on product innovation and the development of new food products, ensure you are aligned with Codex standards, guidelines and codes of practice.  This EAS webinar will host two presenters with a combined total of over 60 years of experience working within the Codex and food manufacturing world to share their insights into how the Codex system works and how to make it a benefit for expanding your business strategy.  Join EAS independent consultant, Richard White and Senior Director for Food Consulting Services, Allen Sayler, to gain new insights into leveraging Codex to add a new dimension to current and future food business strategies. 

About the Presenters

Richard White 

Richard White is a former Director of Codex and International Standards Policy at the Grocery Manufacturers Association. Prior to GMA, he had a career serving US public interests as the Senior Director, Sanitary and Phytosanitary Affairs at the Office of the US Trade Representative and as the Senior Advisor for International Activities in the Office of the Assistant Administrator for Prevention, Pesticides and Toxic Substances at the Environmental Protection Agency. As a consultant he provides expert advice and services regarding international standards, national policies and regulations on food safety and animal and plant health with a focus on the activities of the Codex Alimentarius Commission (CAC) and its subsidiary bodies.

Allen Sayler

Allen Sayler is the Senior Director for Food Consulting Services at EAS with expertise in the areas of food processing, particularly in the area of dairy processing, infant formula, bakery products, food additives, botanical products and food packaging as well as GSFI Third-Party Certification programs such as Safe Quality Foods (SQF). Allen has spent more than 30 years as a food processing and regulatory expert, with half of the time serving the industry and the other have as a state and federal government employee. Prior to joining EAS full time, he was a Managing Partner of the Center for Food Safety & Regulatory Solutions. His international experience includes representing the US food processing industry at the Codex Committees on Food Additives, Food Labeling, Food Hygiene and Milk & Milk Products.

Terms and Conditions

By submitting this form you will be joining the nearly 20,000 who receive the monthly EASeNews regulatory newsletter. Please note EAS never shares your information and you may unsubscribe at any time.