April 4-5, 2018
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.
Dates and Location
April 4-5, 2018
Hilton Garden Inn Denver Downtown
1400 Welton St.
Denver, CO 80202
The Hilton Garden Inn is offering a discounted guest room rate of $129 (plus applicable taxes). Please make your guest room reservation no later than 3/20/2018 and mention EAS Consulting Group to receive this rate.
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.
- Participant’s Manual with copies presentation slides
- Pocket Guide: 21 CFR Part 111
$1000 early-bird rate available until February 15, 2018 (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
Minimum Registration Policy
Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by March 15, 2018 and refund the registration fee in full.
Cancellations received before March 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 Tara Lin Couch, Ph.D. at 571-447-5510 or email@example.com
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 firstname.lastname@example.org