EAS Partners with Vitafoods Europe for Dietary Supplement GMP Training

Posted on April 5, 2019April 12, 2019

May 6, 2019

Geneva, Switzerland

EAS Consulting Group is pleased to announce a partnership with Vitafoods Europe as the exclusive training partner for Dietary Supplement Good Manufacturing Practices (GMPs). EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will present a one-day training on GMPs in advance of the 2019 Vitafoods Europe on Monday 6 May, the day before Vitafoods Europe 2019 official opens its doors.

The training will cover critical information needed to comply with the rules that govern the 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. This training will help firms understand their GMP requirements in an in-person personalized setting, providing an opportunity to learn directly from our GMP expert and ask specific questions regarding GMP issues or situations.

In addition, EAS Independent Advisor for the Food Safety Modernization Act (FSMA), Charles Breen, will speak at the Vitafoods Europe main conference on Supplier Hygienic Commitments and EAS will exhibit at Vitafoods Europe at stand B149. We invite you to stop by the booth or make an appointment to discuss your regulatory US FDA compliance challenges.

Vitafoods Europe is the premier dietary supplement, food and nutraceutical trade show held in Europe. From May 7-9, 2019 thousands of leaders across the globe including suppliers of ingredients, raw materials and the companies which service them will come together to create innovation, connect with business leaders and find effective solutions. Vitafoods is dedicated to covering the entire nutraceutical supply chain – from ingredient to shelf.

Food Labeling Compliance Seminar

Posted on March 22, 2019April 8, 2019

November 14-15, 2019

Irvine, CA

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.

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 with copies of presentation slides
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.)

Agenda

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.

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by October 14, 2019, and refund the registration fee in full.

Cancellation Policy

Cancellations received before September 14, 2019 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.

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 Review Seminar

Posted on March 22, 2019July 1, 2019

November 12-13 2019

Irvine, CA

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.

Instructors

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

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 dietary supplement labels. Consultants, auditors, attorneys and others interested in food labeling compliance.

At the Dietary Supplement Labeling Compliance Seminar, You Will

Learn FDA dietary supplement labeling requirements from regulatory experts.
Be able to ask questions of former FDA officials to get an understanding of how the Agency thinks.
Receive a valuable Participant’s Manual containing all slides and handout materials that will save you time and help assure your labels are in compliance.
Get an opportunity to apply learning in practical work sessions.

Seminar Handouts

Participant’s Manual with copies of presentation slides
EAS Type Size Guide

Agenda

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by October 12, 2019, and refund the registration fee in full.

Cancellation Policy

Cancellations received before September 12, 2019 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.

For More Information

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

In-House Seminar

Contact Cathryn Sacra for a price quote. (571) 447-5500 or csacra@easconsultinggroup.com.

Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar

Posted on March 22, 2019April 8, 2019

November 14-15, 2019

Irvine, CA

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. For instance, out of 483 inspections conducted in 2015, the agency issued approximately 290 Warning Letters. In light of increased FDA oversight, a thorough review on new industry rules on good manufacturing practices (GMPS) is warranted.

EAS Consulting Group will be conducting a Dietary Supplement GMP Seminar to help firms prepare for increased FDA enforcement. Given by former FDA compliance officials and industry experts, this intensive training program will provide all the information needed to comply with the rules, covering the 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.

Instructors

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

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

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.

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 with copies presentation slides
Pocket Guide: 21 CFR Part 111

Agenda

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by October 15, 2019 and refund the registration fee in full.

Cancellation Policy

Cancellations received before September 15, 2019 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.

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

Ensuring Regulatory Compliance of GMP Laboratories

Posted on January 9, 2019April 10, 2019

This one-day intensive program will discuss FDA’s current Good Manufacturing Practice (GMP) requirements for Research and Development and Quality Control Laboratories. The course will cover GMP regulations for physical, analytical, and microbiological laboratories including analyst training and qualification; the labs’ physical facility and environment; instrument qualification, calibration and maintenance programs; laboratory sample control processes; the management of standards and chemicals; the management of data; and overall laboratory documentation. The development, verification, validation, control, and use of test methods as well as transfer thereof will also be discussed. An entire session will be dedicated to the performance of thorough, timely, unbiased, well-documented, and scientifically sound Out-of-Specification (OOS) investigations since this is one of the most critical laboratories quality systems. Tips regarding establishing quality agreements with clients and handling the FDA during an inspection will also be provided.

FDA issues of concern will be highlighted throughout the program with emphasis placed on recent FDA regulatory or administrative actions. All of this will allow participants to gain an understanding of the importance of laboratory GMPs and how to meet FDA’s requirements.

Instructor

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

Dr. Couch is a Ph.D. Analytical / Organic Chemist with over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She possesses exceptional analytical abilities as demonstrated also by her B.S. in Mathematics. She has served as the Study Director on numerous EPA and clinical studies as well as directed the Quality Control department at a pharmaceutical and dietary supplement manufacturing facility. The latter entailed directing all aspects of the quality control analytical and microbiological laboratories including management of the company Stability Program and Quarantine Area operations. Dr. Couch also provided scientific expertise and technical support for new product development, product reformulations, and on-going production challenges. She served as the scientific head of a Strength and Purity Verification Testing Program committee, which provided full label claim testing on dietary supplements to meet all Dietary Supplement Health and Education Act (DSHEA) regulations and expectations of the FDA. Her talents were also utilized to evaluate and set raw material and finished product specifications and prepare product summaries (white papers) for dietary supplement products.
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 is an experienced speaker having presented numerous scientific and regulatory compliance lectures around the country, conducted in-house and external Dietary Supplement GMP trainings, and taught entry level to graduate level chemistry courses and laboratories at several academic institutions.

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel within 45 days of the training and refund the registration fee in full.

Cancellation Policy

Cancellations received before 46 days prior to the training event 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.

For More Information

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

Dietary Supplement GMP Refresher Training

Posted on December 18, 2018March 24, 2019

The Good Manufacturing Practices (GMP) dictated in FDA’s 21 CFR 111 require that "Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must have the education, training, or experience to perform the person's assigned functions". In order to maintain compliance with this requirement, most companies require that employees attend an annual GMP refresher training. Training programs ensure a deeper understanding of how to perform specific job responsibilities in a GMP compliant manner.

EAS Consulting Group, leaders in FDA regulatory is pleased to offer a new one-day refresher training to help firms meet their training requirements in an in-person personalized setting, providing an opportunity to learn directly from our GMP experts and ask specific questions regarding their GMP issues or situations.

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel within 45 days of the training and refund the registration fee in full.

Cancellation Policy

Cancellations received before 46 days prior to the training event 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.

For More Information

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

Dietary Supplement GMP Refresher Training

Posted on December 11, 2018March 24, 2019

Instructor

Robert Fish, Independent Advisor for Quality and Compliance

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.

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel within 45 days of the training and refund the registration fee in full.

Cancellation Policy

Cancellations received before 46 days prior to the training event 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.

For More Information

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

Food Labeling Compliance Review Seminar March 2019

Posted on October 23, 2018January 3, 2019

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 as added sugars and which can be 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 Alexandria, VA and an opportunity to learn from our internationally renowned labeling experts.

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

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 with copies of presentation slides
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.)

Agenda

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by January 2, 2019, and refund the registration fee in full.

Cancellation Policy

Cancellations received before February 12, 2019, 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.

For More Information

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

In-House Seminar

Contact Cathryn Sacra for a price quote. (571) 447-5500 or csacra@easconsultinggroup.com.

Dietary Supplement Labeling Compliance Review Seminar March 2019

Posted on October 23, 2018January 3, 2019

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

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 dietary supplement labels. Consultants, auditors, attorneys and others interested in food labeling compliance.

At the Dietary Supplement Labeling Compliance Seminar, You Will

Learn FDA dietary supplement labeling requirements from regulatory experts.
Be able to ask questions of former FDA officials to get an understanding of how the Agency thinks.
Receive a valuable Participant’s Manual containing all slides and handout materials that will save you time and help assure your labels are in compliance.
Get an opportunity to apply learning in practical work sessions.

Seminar Handouts

Participant’s Manual with copies of presentation slides
EAS Type Size Guide

Agenda

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by January 2, 2019, and refund the registration fee in full.

Cancellation Policy

For More Information:

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

In-House Seminar

Contact Cathryn Sacra for a price quote. (571) 447-5500 or csacra@easconsultinggroup.com.

Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar April 2019

Posted on October 23, 2018December 14, 2018

Between 2010 and 2017 FDA issued 12,444 observations related to GMPs. In light of increased FDA oversight, a thorough review of new industry rules on good manufacturing practices (GMPS) is warranted.

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

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 training via seminar, webinar, and on-site presentations.

Robert Fish, EAS Independent Advisor, Quality and Compliance

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.

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.
Attorneys and others interested in learning about the requirements of the 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 with copies presentation slides
Pocket Guide: 21 CFR Part 111

Agenda

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by January 23, 2019, and refund the registration fee in full.

Cancellation Policy

Cancellations received before March 5, 2019, 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.

For More Information

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

In-House Seminar

Contact Cathryn Sacra for a price quote. (571) 447-5500 or csacra@easconsultinggroup.com.

Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar (including special applications of GMP concepts in the Cannabis Industry)

Posted on July 23, 2018September 7, 2018

With a special section on applying GMP concepts to the Cannabis Industry

Presented in Cooperation with the American Herbal Products Association (AHPA)

The Good Manufacturing Practices (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 addition, as states begin to regulate legalized cannabis, the concern of how 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 can begin to pave the way for putting practices and procedures in place to meet compliance expectations.

EAS Consulting Group in cooperation with the American Herbal Products Association (AHPA) will be conducting a two-day intensive Dietary Supplement GMP Seminar to help firms understand their responsibilities and requirements under 21 CFR 111, while also assisting the cannabis industry in understanding how these principles can be applied to their manufacturing operations. Given by former FDA compliance officials and industry experts, this training program will provide a thorough overview of compliance expectations, covering the 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.

Day 1

Item	Topic	Presenter	Time	Schedule
1	Introduction and GMP Overview	Couch	15	8:00 AM - 8:15 AM
2	FDA Enforcement	Ullman	45	8:15 AM - 9:00 AM
3	Subpart B - Personnel	Fish	30	9:00 AM - 9:30 AM
4	Subpart C - Physical Plant & Grounds	Fish	45	9:30 AM - 10:15 AM
Break			15	10:15 AM - 10:30 AM
5	Subpart D - Equipment & Utensils	Fish	30	10:30 AM - 11:00 AM
6	Subpart G: Components, Packaging, and Labeling	Couch	30	11:00 AM - 11:30 AM
7	Subparts H & I - Master Manufacturing and Batch Production Records	Fish	45	11:30 AM - 12:15 PM
Lunch			45	12:15 PM - 1:00 PM
8	Subparts K & L: Requirements for Manufacturing, Packaging, and Labeling Operations	Fish	30	1:00 PM - 1:30 PM
9	Subpart E: Specifications and Testing	Couch	90	1:30 PM - 3:00 PM
10	Subpart E: Representative and Reserve Samples	Couch	15	3:00 PM - 3:15 PM
Break			15	3:15 PM - 3:30 PM
11	Subparts M: Holding and Distribution Operations	Fish	30	3:30 PM - 4:00 PM
12	Quality Agreements	Ullman	45	4:00 PM - 5:15 PM
13	Work Session I	Couch/Fish	30	4:45 PM - 5:15 PM
14	Additional Q&A	Couch/Fish	15	5:15 PM - 5:30 PM

Day 2

Item	Topic	Presenter	Time	Schedule
1	Documentation and Change Control	Couch	45	8:00 AM - 8:45 AM
2	Subpart F: Quality Control	Couch	30	8:45 AM - 9:15 AM
4	Subpart N: Returned Dietary Supplements	Couch	15	9:15 AM - 9:30 AM
5	Subpart O: Product Complaints	Couch	45	9:30 AM - 10:15 AM
Break			15	10:15 AM - 10:30 AM
6	Investigations and Material Reviews	Couch	60	10:30 AM - 11:30 AM
7	Subpart J: Laboratory Operations	Couch	45	11:30 AM - 12:15 PM
Lunch			30	12:15 PM - 1:00 PM
8	Dietary Supplement Test Methods	Couch	45	1:00 PM - 1:45 PM
9	Dietary Supplement Stability Programs	Couch	45	1:45 PM - 2:30 PM
10	Work Session II	Couch/Ullman	30	2:30 PM - 3:00 PM
Break			15	3:00 PM - 3:15 PM
11	Managing FDA Inspections	Ullman	90	3:15 PM - 4:45 PM
12	Exam	Couch	15	4:45 PM - 5:00 PM

Who Should Attend?

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

At the Dietary Supplement GMP Seminar, You Will

Receive detailed practical guidance on how to apply the GMP 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 with copies of the presentation slides
Pocket Guide: 21 CFR Part 111

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

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 training via seminar, webinar, and on-site presentations.

Robert Fish, EAS Independent Advisor, Quality and Compliance

Mr. Fish joined EAS Consulting Group, LLC in November 2006 after 10 years consulting for FDA regulated industries. He spent 33 years with the Food and Drug Administration (FDA), the last six 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.

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 10 years, where he represented clients in both federal and state prosecutions, as well as numerous related civil matters and other litigations.

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by August 15, 2018, and refund the registration fee in full.

Cancellation Policy

Cancellations received before August 15, 2018, 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.

For More Information

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

In-House Seminar

Dietary Supplement Labeling Compliance Review Seminar

Posted on July 23, 2018August 28, 2018

Dietary supplement manufacturers need to keep up to date on new and changing FDA labeling policies. Now that FDA has published the final GMP regulations it is anticipated that the regulation of dietary supplements will be given a higher priority. This will undoubtedly carry over to an increased focus on labeling compliance. This seminar will provide 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.

Who Should Attend?

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

At the Dietary Supplement Labeling Compliance Seminar, You Will

Learn FDA dietary supplement labeling requirements from regulatory experts.
Be able to ask questions of former FDA officials to get an understanding of how the Agency thinks.
Receive a valuable Participant’s Manual containing all slides and handout materials that will save you time and help assure your labels are in compliance.
Get an opportunity to apply learning in practical work sessions.

Seminar Handouts

Participant’s Manual with copies of presentation slides
EAS Type Size Guide

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

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.

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by July 1, 2018, and refund the registration fee in full.

Cancellation Policy

Cancellations received before July 1, 2018, 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.

For More Information:

Contact Amy Scanlin at (571) 447-5500 or ascanlin@easconsultinggroup.com

In-House Seminar

Food Labeling Compliance Review Seminar

Posted on July 23, 2018August 28, 2018

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 as added sugars and which can be 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 Alexandria, VA and an opportunity to learn from our internationally renowned labeling experts.

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 with copies of presentation slides
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.)

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.

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by July 1, 2018, and refund the registration fee in full.

Cancellation Policy

For More Information

Contact Amy Scanlin at (571) 447-5500 or ascanlin@easconsultinggroup.com

May 6, 2019

Geneva, Switzerland

November 14-15, 2019

Irvine, CA

Registration

Date and Location

Who Should Attend?

At the Food Labeling Compliance Seminar, You Will

Seminar Handouts

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

Gisela Leon, EAS Independent Consultant

Minimum Registration Policy

Cancellation Policy

For More Information

In-House Seminar

November 12-13 2019

Irvine, CA

Registration

Dates and Location

Instructors

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

Gisela Leon, EAS Independent Consultant

Who Should Attend?

At the Dietary Supplement Labeling Compliance Seminar, You Will

Seminar Handouts

Minimum Registration Policy

Cancellation Policy

For More Information

In-House Seminar

November 14-15, 2019

Irvine, CA

Registration

Dates and Location

Instructors

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

Robert Fish, EAS Independent Advisor, Quality and Compliance

Marc Ullman, Of Counsel at Rivkin Radler, LLP.

Who Should Attend?

At the Dietary Supplement GMP Seminar, You Will

Seminar Handouts

Minimum Registration Policy

Cancellation Policy

For More Information

In-House Seminar

April 23, 2019

Denver, CO

Registration

Discounts

Includes:

Dates and Location

Instructor

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

Who Should Attend?

Minimum Registration Policy

Cancellation Policy

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November 12, 2019

Plainview, NY

Dates and Location

Registration

Discounts

Includes:

Instructor

Heather Fairman, Independent Consultant

Who Should Attend?

Minimum Registration Policy

Cancellation Policy

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May 7, 2019

Denton, TX

Dates and Location

Registration

Discounts

Includes:

Instructor

Robert Fish, Independent Advisor for Quality and Compliance

Who Should Attend?

Minimum Registration Policy

Cancellation Policy

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