Dietary Supplement GMP Refresher Training 2019 NY

Dietary Supplement GMP Refresher Training

November 12, 2019

Plainview, NY

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.

Dates and Location

November 12, 2019

Plainview, NY (Long Island area)

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

Registration

$300

Register

Discounts

Group Rate, two or more from the same firm – 10% per person (GROUP10)
Federal/State Government Employees – 10% per person (GOV10)

Registrants with Promotion codes - Limit one Promotion code per transaction

Includes:

  • Participant’s Manual with presentation slides
  • Pocket Guide: 21 CFR Part 111
  • Lunch

Instructor

Heather Fairman, Independent Consultant

Who Should Attend?

  • Individuals involved in the manufacturing, labeling, packaging, storing and distribution of dietary supplements. In addition, members of the management, regulatory affairs, and quality control/assurance teams would benefit from this training.
  • Attorneys and others interested in learning about the requirements of the dietary supplement GMPs and how they should be applied.

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

Dietary Supplement GMP Refresher Training 2019 MA

Dietary Supplement GMP Refresher Training

August 13, 2019

Andover, MA

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.

Dates and Location

August 13, 2019

Andover, MA (Boston area)

Registration

$300

Register

Discounts

Group Rate, two or more from the same firm – 10% per person (GROUP10)
Federal/State Government Employees – 10% per person (GOV10)

Registrants with Promotion codes - Limit one Promotion code per transaction

Includes:

  • Participant’s Manual with presentation slides
  • Pocket Guide: 21 CFR Part 111
  • Lunch

Instructor

Tamika Cathey, Independent Consultant

Who Should Attend?

  • Individuals involved in the manufacturing, labeling, packaging, storing and distribution of dietary supplements. In addition, members of the management, regulatory affairs, and quality control/assurance teams would benefit from this training.
  • Attorneys and others interested in learning about the requirements of the dietary supplement GMPs and how they should be applied.

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

Dietary Supplement GMP Refresher Training 2019 TX

Dietary Supplement GMP Refresher Training

May 7, 2019

Denton, TX

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.

Dates and Location

May 7, 2019

Denton, TX (Dallas-Fort Worth area)

Registration

$300

Register

Discounts

Group Rate, two or more from the same firm – 10% per person (GROUP10)
Federal/State Government Employees – 10% per person (GOV10)

Registrants with Promotion codes - Limit one Promotion code per transaction

Includes:

  • Participant’s Manual with presentation slides
  • Pocket Guide: 21 CFR Part 111
  • Lunch

Instructor

Robert Fish, Independent Advisor for Quality and Compliance

Robert FishMr. 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.

Who Should Attend?

  • Individuals involved in the manufacturing, labeling, packaging, storing and distribution of dietary supplements. In addition, members of the management, regulatory affairs, and quality control/assurance teams would benefit from this training.
  • Attorneys and others interested in learning about the requirements of the dietary supplement GMPs and how they should be applied.

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

Dietary Supplement GMP Refresher Training 2019 CA

Dietary Supplement GMP Refresher Training

February 5, 2019

Riverside, CA

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.

Dates and Location

February 5, 2019

Riverside, CA (Los Angeles area)

Registration

$300

Register

Discounts

Group Rate, two or more from the same firm – 10% per person (GROUP10)
Federal/State Government Employees – 10% per person (GOV10)

Registrants with Promotion codes - Limit one Promotion code per transaction

Includes:

  • Participant’s Manual with presentation slides
  • Pocket Guide: 21 CFR Part 111
  • Lunch

Instructor

Timothy Stewart, Ph.D., Independent Advisor for Dietary Supplements

Tim Stewart Ph.D.Tim Stewart is a Ph.D. chemist who advises clients on FTC, AG and FDA regulatory compliance issues such as Customs and Border Patrol, Import Alerts, State and Federal observations/violations, Consent Decrees, California Proposition 65 requirements, and vendor qualifications.  Prior to consulting, he worked at Paragon Laboratories as a Quality Control Manager and researcher at both Harvard Medical School and the University of Southern California.

Who Should Attend?

  • Individuals involved in the manufacturing, labeling, packaging, storing and distribution of dietary supplements. In addition, members of the management, regulatory affairs, and quality control/assurance teams would benefit from this training.
  • Attorneys and others interested in learning about the requirements of the dietary supplement GMPs and how they should be applied.

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

Food Labeling Compliance Review Seminar March 2019

March 12-13, 2019

Philadelphia, PA

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.

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

Register

Discounts

Earlybird discount rate of $200, ends January 2, 2019

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

March 12-13, 2019

Warwick Hotel Rittenhouse Square
220 South 17th Street
Philadelphia, PA 19103
215.735.6000
www.warwickrittenhouse.com

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 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

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 March 2019

March 14-15, 2019

Philadelphia, PA

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

Register

Discounts

Earlybird discount rate of $200, ends January 2, 2019

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

March 14-15, 2019

Warwick Hotel Rittenhouse Square
220 South 17th Street
Philadelphia, PA 19103
215.735.6000
www.warwickrittenhouse.com

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

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

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 April 2019

April 2-3, 2019

Philadelphia, PA

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.

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

$1,200

Register

Discounts

Earlybird discount rate of $200, ends February 2, 2019

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

April 2-3, 2019

Warwick Hotel Rittenhouse Square
220 South 17th Street
Philadelphia, PA 19103
215.735.6000
www.warwickrittenhouse.com

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 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

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 (including special applications of GMP concepts in the Cannabis Industry)

September 26-27, 2018

Dallas, Texas

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.

Registration

$1,200

Discounts

$1,000 All AHPA members (use discount code: EAS_AHPA)

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

September 26-27, 2018

Hotel Indigo

1933 Main Street
Dallas, TX 75201
1-877-8IN-DIGO

The Hotel Indigo has extended a discounted guest room rate to registrants of the EAS-AHPA Dietary Supplement GMP seminar. Please make your guest room reservation no later than September 5, 2018, using this dedicated registration link or call the hotel directly and mention EAS Consulting Group.

Agenda

Day 1

ItemTopicPresenterTimeSchedule
1Introduction and GMP OverviewCouch158:00 AM - 8:15 AM
2FDA EnforcementUllman458:15 AM - 9:00 AM
3Subpart B - PersonnelFish309:00 AM - 9:30 AM
4Subpart C - Physical Plant & Grounds
Fish459:30 AM - 10:15 AM
Break1510:15 AM - 10:30 AM
5Subpart D - Equipment & Utensils
Fish3010:30 AM - 11:00 AM
6Subpart G: Components, Packaging, and Labeling
Couch3011:00 AM - 11:30 AM
7Subparts H & I - Master Manufacturing and Batch Production Records
Fish4511:30 AM - 12:15 PM
Lunch4512:15 PM - 1:00 PM
8Subparts K & L: Requirements for Manufacturing, Packaging, and Labeling Operations
Fish301:00 PM - 1:30 PM
9Subpart E: Specifications and Testing
Couch901:30 PM - 3:00 PM
10Subpart E: Representative and Reserve Samples
Couch153:00 PM - 3:15 PM
Break153:15 PM - 3:30 PM
11Subparts M: Holding and Distribution OperationsFish303:30 PM - 4:00 PM
12Quality AgreementsUllman454:00 PM - 5:15 PM
13Work Session ICouch/Fish304:45 PM - 5:15 PM
14Additional Q&ACouch/Fish
155:15 PM - 5:30 PM

Day 2

ItemTopicPresenterTimeSchedule
1Documentation and Change Control
Couch458:00 AM - 8:45 AM
2Subpart F: Quality Control
Couch308:45 AM - 9:15 AM
4Subpart N: Returned Dietary Supplements
Couch159:15 AM - 9:30 AM
5Subpart O: Product Complaints
Couch459:30 AM - 10:15 AM
Break1510:15 AM - 10:30 AM
6Investigations and Material ReviewsCouch6010:30 AM - 11:30 AM
7Subpart J: Laboratory OperationsCouch4511:30 AM - 12:15 PM
Lunch3012:15 PM - 1:00 PM
8Dietary Supplement Test MethodsCouch451:00 PM - 1:45 PM
9Dietary Supplement Stability ProgramsCouch451:45 PM - 2:30 PM
10Work Session IICouch/Ullman302:30 PM - 3:00 PM
Break153:00 PM - 3:15 PM
11Managing FDA InspectionsUllman903:15 PM - 4:45 PM
12ExamCouch154:45 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

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 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

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 us for more information.

Dietary Supplement Labeling Compliance Review Seminar

September 26-27, 2018

Kansas City, Missouri

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.

Registration

$1,200

Discounts

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

September 26-27, 2018

Hampton Inn Kansas City/Downtown Financial District
801 Walnut Street
Kansas City, Missouri, 64106

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

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.

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

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 us for more information.

Food Labeling Compliance Review Seminar

September 24-25, 2018

Kansas City, Missouri

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.

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 Fees

$1,200

Discounts

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

September 24-25, 2018

Hampton Inn Kansas City/Downtown Financial District
801 Walnut Street
Kansas City, Missouri, 64106

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.)

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.

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

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 us for more information.