(571) 447-5500

Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar

September 27, 29, October 4, 6, 2022 • Virtual Event

11am-4pm Eastern each day

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 tenets of the regulation. In light of increased FDA oversight, a thorough review of industry rules for Good Manufacturing Practices (GMPS) is warranted.

In these unprecedented times, the dietary supplement industry is playing an essential role for the U.S. consumer. Never before have more questions been raised regarding Good Manufacturing Practices (GMPs), so we are offering our Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar course virtually.

GMPs, dictated in 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, have been in place for over a decade. Even with the Food and Drug Administration’s (FDA) efforts to ensure consistent manufacturing to established product specifications, industry confusion with the basic tenets of the regulation result in numerous FDA observations and Warning Letters. A thorough understanding of 21 CFR 111, as well as other statutory requirements is critical for compliance and safety for the consumer, both of which are required for the success of a company.

EAS Consulting Group Dietary Supplement GMP Seminar helps firms prepare for 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.

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 all of the requirements of 21 CFR 111 and other applicable statutory requirements.
  • Receive detailed practical guidance on how to apply these requirements at your facility.
  • Get coaching on how to prepare for an FDA inspection and avoid receiving a List of Objectionable Inspection Observations (Form FDA 483).
  • Be given an opportunity to demonstrate your understanding of GMPs in group work sessions.

Seminar Handouts

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

Instructors

Tara Lin Couch, Ph.D.

EAS Senior Director for Dietary Supplement and Tobacco Services

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

Tara serves on various industry committees for the Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA), and the Food, Drug Law Institute (FDLI). She is also active in the American Herbal Products Association (AHPA).

Tamika Cathey

EAS Independent Consultant

Tamika Cathey consults with an international client base on regulations pertaining to safety and quality of pharmaceuticals and dietary supplements. She evaluates client compliance readiness by conducting audits, risk assessments and mock FDA/GMP investigations and works to design improvement programs based on findings. Tamika has a B.S. in Biology from Greensboro College in North Carolina. Prior to consulting she held positions such as Associate Director, Regulatory Affairs for Charles River Laboratories, and Consumer Safety Officer at FDA’s Atlanta District.

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.

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

Registration

$749.00$849.00

Clear

All seminar registrations are per person.

On-line Training

The EAS Consulting Group Dietary Supplement GMP Seminar will be conducted virtually through Zoom. A link will be provided to each participant. To ensure an understanding with the instructional material, live student attendance and active participation in discussions via webcam is required. At the conclusion of the training, students must complete a GMP exam with an acceptable score in order to receive their certificate of training. Each attendee will receive the entire presentation and a 21 CFR Part 111 Pocket Guide in advance of the course.

 

Virtual Seminar Dates and Times

The virtual seminar will take place from 11:00am – 4:00pm eastern. Please verify your schedule prior to registration. Attendance at each seminar date is expected.

Group Rate, two or more from the same firm
Use group10 for multiple attendees from one company.

Registrants with Promotion codes – Limit one Promotion code per transaction.

Cancellation Policy
EAS reserves the right to cancel the seminar if minimum participation has not been met two weeks prior to the start of the seminar. All registrations will be refunded in full.

Cancellations will be refunded minus a $95 processing fee up to two weeks prior to the start date of the seminar. After this date, no refunds will be given.

Terms and Conditions
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For More Information

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