Food Labeling Compliance Seminar

July 21-22, 2020

Long Island, NY

EAS’ Food Labeling Compliance Seminar has been awarded 16 CEU credits by the Commission on Dietetic Registration.

As the food industry turns its focus to compliance with the latest FDA guidance for labeling regulations, the significance of those changes and how they influence claims are raising questions. Which ingredients must be declared added sugars and which can be as dietary fiber? EAS Consulting Group, with our vast expertise in assisting food firms in all manners of FDA compliance is offering a food labeling compliance seminar in Philadelphia, PA and an opportunity to learn from our internationally renowned labeling experts.

Learn food labeling regulations from internationally renowned experts, who had primary roles at FDA in shaping current labeling regulations and experience in the development of thousands of food labels.

This hands-on, two-day seminar covers the basics of how foods need to be labeled to comply with the complex set of labeling rules, covers the latest in food labeling issues that have gotten attention from FDA, and provides answers to your most challenging questions.

Registration

$1,200

Group Rate, two or more from the same firm – 10% per person (group10)

Federal/State Government Employees – 50% per person (gov50)

Early-bird pricing in effect through May 1, 2020. Use “earlybird” to receive 10% off registration at checkout.

Registrants with Promotion codes – Limit one Promotion code per transaction

Location

Hilton Garden Inn Melville
1575 Round Swamp Road
Plainview, New York 11803

Hilton Garden Inn is offering a discounted guest room rate for seminar attendees. Click here to be directed to their reservations page.

Instructors

James E. Hoadley, Ph.D., EAS Independent Consultant

During Dr. Hoadley’s 20-year FDA career, he participated in the development of NLEA-implementing nutrition labeling and health claim regulations. As a Senior Regulatory Scientist in the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) Dr. Hoadley’s primary responsibilities were in food label claim regulations. In this role, he conducted scientific and regulatory reviews of petitions for new health claims and nutrient content claims.

Gisela Leon, EAS Independent Consultant

Gisela Leon brings in over 21 years of experience in international labeling of food and over 8 years’ experience in US labeling. As a regulatory consultant, she has focused on a concise review process for food, dietary supplements, and cosmetics. As a long term EAS Consultant she has reviewed hundreds of labels for US compliance and helped international products to come into compliance with US regulations. Her international labeling background allows her to point out differences or similarities with other countries.

Who Should Attend?

  • Individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing of foods.
  • Those responsible for preparing or reviewing food labels.
  • Consultants, auditors, attorneys and others interested in food labeling compliance.

At the Food Labeling Compliance Seminar, You Will

  • Learn FDA food labeling requirements from labeling experts who helped to develop and implement the current regulations and have reviewed hundreds of labels for the industry.
  • Learn about hot issues that have triggered recent FDA warning letters.
  • Apply learning in practical work sessions.
  • Have your specific issues addressed and discussed in a casual, interactive learning environment.

Seminar Handouts

  • Participant’s Manual 
  • EAS Type Size Guide
  • Food Label Handbook – Developed by EAS Independent Consultant, Gisela Leon, the 115-page guide discusses how changes to nutrient values are listed and how those changes impact claims, assisting companies in developing compliant food labels based on FDA’s final rule. (A $99 value.)

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by May 20, 2020, and refund the registration fee in full.

Cancellation Policy

Cancellations received before May 20, 2020 will result in a $95 processing fee. No refunds will be given for cancellations received after that date. Substitutions will be allowed as long as notice is given to EAS in advance.

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.

For More Information

Contact Amy Scanlin at (571) 447-5508 or ascanlin@easconsultinggroup.com

In-House Seminar

EAS will conduct this seminar for individual firms upon request. Bringing the seminar in-house at your facilities can be a cost-effective alternative to train your employees. It also allows the program to be tailored to your particular needs. Contact Cathryn Sacra for a price quote. (571) 447-5500 or csacra@easconsultinggroup.com.

Dietary Supplement Labeling Compliance Seminar

July 23-24, 2020

Long Island, NY

Dietary supplement manufacturers need to keep up to date on new and changing FDA labeling policies as they will undoubtedly carry over to an increased focus on labeling enforcement. This seminar provides all that is necessary to prepare labels that comply with FDA requirements. It will address the regulatory requirements for the mandatory labeling elements and will cover allowable dietary supplement claims. Attendees will participate in a workgroup exercise to facilitate their understanding of the regulations as well as understand how dietary supplement label requirements differ from those of foods and issues that have triggered FDA enforcement actions.

Registration

$1,200

Group Rate, two or more from the same firm – 10% per person (group10)

Federal/State Government Employees – 50% per person (gov50)

Early-bird pricing in effect through May 1, 2020. Use “earlybird” to receive 10% off registration at checkout.

Registrants with Promotion codes – Limit one Promotion code per transaction

Location

Hilton Garden Inn Melville
1575 Round Swamp Road
Plainview, New York 11803

Hilton Garden Inn is offering a discounted guest room rate for seminar attendees. Click here to be directed to their reservations page.

Instructors

James E. Hoadley, Ph.D., EAS Independent Consultant

During Dr. Hoadley’s 20-year FDA career, he participated in the development of NLEA-implementing nutrition labeling and health claim regulations. As a Senior Regulatory Scientist in the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) Dr. Hoadley’s primary responsibilities were in food label claim regulations. In this role, he conducted scientific and regulatory reviews of petitions for new health claims and nutrient content claims.

Gisela Leon, EAS Independent Consultant

Gisela Leon brings in over 21 years of experience in international labeling of food and over 8 years’ experience in US labeling. As a regulatory consultant, she has focused on a concise review process for food, dietary supplements, and cosmetics. As a long term EAS Consultant she has reviewed hundreds of labels for US compliance and helped international products to come into compliance with US regulations. Her international labeling background allows her to point out differences or similarities with other countries.

Who Should Attend?

  • Individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing of dietary supplements.
  • Those responsible for preparing or reviewing supplement labels.
  • Consultants, auditors, attorneys and others interested in supplement labeling compliance.

At the Dietary Supplement Labeling Compliance Seminar, You Will

  • Learn FDA supplement facts panel labeling requirements from labeling experts who helped to develop and implement the current regulations and have reviewed hundreds of labels for the industry.
  • Learn about hot issues that have triggered recent FDA warning letters.
  • Apply learning in practical work sessions.
  • Have your specific issues addressed and discussed in a casual, interactive learning environment.

Seminar Handouts

  • Participant’s Manual 
  • EAS Type Size Guide
  • Dietary Supplement Label Handbook – Developed by EAS Independent Consultant, Gisela Leon, the 115-page guide discusses how changes to nutrient values are listed and how those changes impact claims, assisting companies in developing compliant food labels based on FDA’s final rule. (A $99 value.)

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by May 20, 2020, and refund the registration fee in full.

Cancellation Policy

Cancellations received before May 20, 2020 will result in a $95 processing fee. No refunds will be given for cancellations received after that date. Substitutions will be allowed as long as notice is given to EAS in advance.

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.

For More Information

Contact Amy Scanlin at (571) 447-5508 or ascanlin@easconsultinggroup.com

In-House Seminar

EAS will conduct this seminar for individual firms upon request. Bringing the seminar in-house at your facilities can be a cost-effective alternative to train your employees. It also allows the program to be tailored to your particular needs. Contact Cathryn Sacra for a price quote. (571) 447-5500 or csacra@easconsultinggroup.com.

Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar

July 21-22, 2020

Long Island, NY

The GMPs dictated in 21 CFR 111 have been in place for over a decade, but the FDA continues to issue numerous Warning Letters to the industry for a failure to comply with even the basic tenants of the regulation. In light of increased FDA oversight, a thorough review of industry rules for Good Manufacturing Practices (GMPS) is warranted.

EAS Consulting Group Dietary Supplement GMP Seminar helps firms prepare for increased FDA enforcement by facilitating an understanding of compliance requirements for responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved with the testing, quality control and distribution of supplements.

Instructed by former a FDA compliance official, industry expert on GMPs, and a food and drug attorney, this intensive training program will help your firm stay on top of GMP requirements. 

Registration

$1,200

Group Rate, two or more from the same firm – 10% per person (use discount code group10)

Federal/State Government Employees – 50% per person (use discount code gov50)

Early-bird pricing in effect through May 1, 2020. Use “earlybird” to receive 10% off registration at checkout.

Registrants with Promotion codes – Limit one Promotion code per transaction

Location

Hilton Garden Inn Melville
1575 Round Swamp Road
Plainview, New York 11803

Hilton Garden Inn is offering a discounted guest room rate for seminar attendees. Click here to be directed to their reservations page.

Instructors

Dr. Tara Lin Couch, EAS Senior Director, Dietary Supplement and Tobacco Services

Tara Couch PhD

Dr. 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 both pharmaceutical and dietary supplement manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a consultant Dr. Couch has assisted numerous dietary supplement 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 trainings via seminar, webinar, and on-site presentations.

Robert Fish, EAS Independent Advisor, Quality and Compliance

Robert Fish

Mr. Fish joined EAS Consulting Group, LLC in November 2006 after ten years consulting for FDA regulated industries. He spent 33 years with Food and Drug Administration (FDA), the last 6 years of that service as Director, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Prior to that position, Mr. Fish was Director of Compliance at the Nashville District Office and was also a Supervisory Investigator at the Nashville District Office. Mr. Fish began his career as an investigator in the Minneapolis District Office in 1962, and subsequently served as an Investigator at the Grand Rapids Residence Post and the Detroit District Office. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and Current Good Manufacturing Practice Regulations (GMPs) as they relate to pharmaceutical, device, and biologics manufacture. Further, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert, speaking at international events on FDA inspections and GMPs.

Marc Ullman, Of Counsel at Rivkin Radler, LLP.

Marc Ullman

Attorney Marc Ullman represents clients in matters relating to all aspects of the firm’s practice, including Food and Drug Administration and Drug Enforcement Administration matters, regulatory issues, Federal Trade Commission proceedings and litigation. He practiced with one of New York’s leading white-collar criminal defense firms for ten years, where he represented clients in both federal and state prosecutions, as well as numerous related civil matters and other litigations.

Who Should Attend?

  • Individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing, labeling, packaging, storing and distribution of dietary supplements.
  • Consultants, auditors, attorneys and others interested in learning about the requirements of the new dietary supplement GMPs and how they should be applied.

At the Dietary Supplement GMP Seminar, You Will

  • Learn the requirements of the final Rule and understand how they differ from the proposed rule that was published in March 2003
  • Receive detailed practical guidance on how to apply these requirements.
  • Be given an opportunity to demonstrate your understanding of GMPs in group work sessions Be coached on how to prepare for an FDA inspection and how to avoid receiving a List of Objectionable Inspection Observations (Form FDA 483) and the end of an FDA inspection.

Seminar Handouts

  • Participant’s Manual 
  • Pocket Guide: 21 CFR Part 111

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by May 20, 2020 and refund the registration fee in full.

Cancellation Policy

Cancellations received May 20, 2020 will result in a $95 processing fee. No refunds will be given for cancellations received after that date. Substitutions will be allowed as long as notice is given to EAS in advance.

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.

For More Information

Contact Amy Scanlin at ascanlin@easconsultinggroup.com or 571-447-5508 

In-House Seminar

EAS will conduct this seminar for individual firms upon request. Bringing the seminar in-house to your facilities can be a cost-effective alternative to train your employees. It also allows the program to be tailored to your particular needs.

Contact Tara Lin Couch, Ph.D. for a price quote. 571-447-5510 or tcouch@easconsultinggroup.com