Category Archives: Seminar

EAS On-Line Short Course: Hygienic Equipment Sanitation – Best Practices for Food Safety

Posted on

Presented by EAS Independent Consultants David Blomquist and Jennifer Kane

A Three-Part Series – January 29, February 5 and February 12, 2020

Cost: $99 for EAS Clients $149 non-EAS Clients

This short course offers practical information on best practices, “real-world” examples and tips on how to enhance daily operations related to improving existing food safety and quality programs. The three-session training will focus on criteria for selecting, installing and maintaining processing equipment and utensils, how to effectively clean processing equipment and the processing environment, identification of employee practices that negatively impact operational food safety as well as how to upgrade existing food safety programs using industry “best practices” for compliance with FDA Food Safety Modernization Act (FSMA) regulations.

Your instructors will utilize extensive experience in auditing and troubleshooting wet and dry food processing environments to deliver real-world advice on upgrading food safety programs through the use of common sense, mining production records and associated data, the use of cutting-edge technology and tools, microbiological indicators, environmental testing programs and hazard detection systems. You will learn how to identify food safety “alarm bells” and how to silence them through the establishment of early warning systems alerting quality assurance, food safety and management before significant problems emerge.

This Short Course is perfect for:

  • food safety, food quality, facility maintenance, equipment maintenance and operational supervisors and directors at the manufacturing and corporate levels
  • manufacturing facility plant and corporate management directly or indirectly responsible for food safety and quality
  • manufacturing facility and corporate management responsible for purchasing, installing, maintaining, operating, cleaning and sanitizing of snack food processing equipment
  • suppliers providing food processing equipment, cleaning and sanitation systems and equipment integrators services 

Session Agendas

Session 1
January 29, 2020,
at 1 PM Eastern

Presenter: Jenifer Kane

Introduction – Why is this important? (includes Case Studies, Recent Recalls, Lawsuits Impacting the Food Industry – Lessons Learned)

Regulatory Expectations: FDA Preventive Control’s Sanitation Requirements

  1. Allergens
  2. Microbiology and pathogens
  3. Hygienic zoning
  4. Environmental monitoring program

Session 2
February 5, 2020,
at 1 PM Eastern

Presenter: David Blomquist

Hygienic Design, Installation and Maintenance of Food Processing Equipment Identifying “Harborage Traps” and Correcting

Sanitation Technology & Tools

  1. Chemistry of Cleaning Different “Soils”
  2. Chemistry of Sanitation on Different Surfaces and for Different Bacteria
  3. Wet Cleaning Systems – Effective Use of CIP & COP Systems
  4. Dry Cleaning Systems – Effective Use of Air, Vacuum, CO2, 7 steps of dry cleaning, etc.
  5. Effective Use of Cleaning and Sanitation Data

Session 3
February 12, 2020,
at 1 PM Eastern

Presenters: Jenifer Kane and David Blomquist

Recognizing and Mitigation Key Sanitation Challenges Originating from the Processing Environment, Processing Equipment, Ingredients & Employees

  1. Allergens
  2. Pathogens
  3. Common Physical Hazards

Tools for Validation and Verification of Snack Food Sanitation Programs 

  1. Effective Environmental Monitoring
  2. ATP Swabbing
  3. Whole Genome Sequencing – Understanding the Value and Shortcomings
  4. “Mining” Operational Records 

About the Presenters:

David Blomquist

David Blomquist spent much of his career as a technical support specialist at the Ecolab food and beverage division. His early career included Quality Assurance and Quality Control roles in several food operations. He also served in the Peace Corps in Morocco and worked as a chemist, testing products in the Moroccan equivalent of the U.S. FDA. 

Jenifer Kane

Jenifer Kane is a Food Safety and Quality professional with over 36 years of diversified technical and practical experience in the Quality and Food Safety field across multiple food categories. Her expertise includes quality systems, program and audit development and implementation with focus on training in food safety, allergen and HACCP requirements are key strengths. Jenifer has diverse food category experience with a focus on nuts, chocolate, cereal, confections, dairy and bakery products. She is a FSMA FSPCA Trainer and FSPCA Alliance lead instructor.

Food Labeling Compliance Seminar

Posted on

April 16-17, 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

Earlybird registration of $1,000 available until February 15, 2020 (use discount code earlybird)

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

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

Registrants with Promotion codes – Limit one Promotion code per transaction

Location

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

https://www.hilton.com/en/hotels/jfkmlgi-hilton-garden-inn-melville/

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 March 1, 2020, and refund the registration fee in full.

Cancellation Policy

Cancellations received before February 15, 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

Posted on

April 14-15, 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

Earlybird registration of $1,000 available until February 15, 2020 (use discount code earlybird)

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

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

Registrants with Promotion codes – Limit one Promotion code per transaction

Location

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

https://www.hilton.com/en/hotels/jfkmlgi-hilton-garden-inn-melville/

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 March 1, 2020, and refund the registration fee in full.

Cancellation Policy

Cancellations received before February 15, 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

Posted on

April 16-17, 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

$1000 early-bird rate available until February 15, 2020 (use discount code earlybird)

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)

Registrants with Promotion codes – Limit one Promotion code per transaction

Location

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

https://www.hilton.com/en/hotels/jfkmlgi-hilton-garden-inn-melville/

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 
  • 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 March 1, 2020 and refund the registration fee in full.

Cancellation Policy

Cancellations received February 15, 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

Food Labeling Compliance Seminar

Posted on

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.

Registration

Register

$1,200

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

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

Registrants with Promotion codes – Limit one Promotion code per transaction

Date and Location

November 14-15, 2019

Hilton Garden Inn Irvine/Orange County Airport
2381 Morse Avenue
Irvine, CA 92614
(949) 224-3900
www.Irvineorangecountyairport.hgi.com

Hotel reservations can be made by calling the hotel at 949-224-3900 and asking for the EAS Consulting rate of $179+ tax, or by using the following booking link: EAS Consulting Booking Link. Cut-off date for receiving this negotiated rate with the hotel is October 19, 2019.

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.)

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.

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 Review Seminar

Posted on

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.

Registration

Register

$1,200

Earlybird registration rate of $1,000 available through July 12, 2019 (use code earlybird at checkout)

Group Rate, two or more from the same firm – 10% per person (GROUP10)

Federal/State Government Employees – 50% per person (GOV50)

Registrants with Promotion codes – Limit one Promotion code per transaction

Dates and Location

November 12-13, 2019

Hilton Garden Inn Irvine/Orange County Airport
2381 Morse Avenue
Irvine, CA 92614
(949) 224-3900
www.Irvineorangecountyairport.hgi.com

Hotel reservations can be made by calling the hotel at 949-224-3900 and asking for the EAS Consulting rate of $179+ tax, or by using the following booking link: EAS Consulting Booking Link. Cut-off date for receiving this negotiated rate with the hotel is October 19, 2019.

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 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

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

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

Posted on

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.

Registration

Register

$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)

Registrants with Promotion codes – Limit one Promotion code per transaction

Dates and Location

November 14-15, 2019

Hilton Garden Inn Irvine/Orange County Airport
2381 Morse Avenue
Irvine, CA 92614
(949) 224-3900
www.Irvineorangecountyairport.hgi.com

Hotel reservations can be made by calling the hotel at 949-224-3900 and asking for the EAS Consulting rate of $179+ tax, or by using the following booking link: EAS Consulting Booking Link. Cut-off date for receiving this negotiated rate with the hotel is October 19, 2019.

 

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

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.

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