(571) 447-5500

Dietary Supplement Good Manufacturing Practices (GMP) Compliance Virtual Seminar

September 22, 23, 29 & 30, 2020 • Virtual Event

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.

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 2-day Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar course virtually over four days in September.

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 tenants 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

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.

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

$800.00

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 on the following dates. Please verify your schedule prior to registration. Attendance at each seminar date is expected.

Session 1: September 22, 2020,

Session 2: September 23, 2020

Session 3: September 29, 2020

Session 4: September 30, 2020

Terms and Conditions
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For More Information

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