Ullman Presents at EAS Dietary Supplement GMP Compliance Seminar

January 16, 2018 | Marc S. Ullman | Compliance Investigations & White Collar

Marc Ullman will be a presenter at the Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar, to be held April 4-5 in Denver, CO.

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.

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 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.

Click here to register.  Note:  $1,000 early bird rate available until February 1, 2018.

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