Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar
The FDA conducted nearly double the number of facility inspections for Dietary Supplement Firms in 2012 over 2011 and issued approximately 38 Warning Letters. 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 in the testing, quality control and distribution of supplements.
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.
Good Manufacturing Practices in the Dietary Supplement Laboratory
EAS Consulting Group offers a one-day intensive seminar on Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. Learn how to establish and maintain, or identify, an adequate laboratory facility with effective laboratory controlled processes that follow thorough, detailed written procedures. Get a basic understanding of what analytical techniques are available and when they are appropriate to establish that dietary ingredient and dietary supplement product specifications for identity, purity, strength, composition, and potential contaminants have been met. Find out what a scientifically valid test method is and how to experimentally demonstrate it. When specifications are not met, learn how to conduct a scientifically sound out of specification (OOS) investigation. Finally, understand what it takes to sustain good documentation practices in a laboratory setting.
Covering topics such as:
- 21 CFR 111 GMP Laboratory Overview
- Using Analytical Instrumentation Appropriately
- What is a Scientifically Valid Method?
- Developing Compliant Specifications – No “By Inputs” Here
- How to Select and Qualify a Contract Laboratory
- Conducting a scientifically sound out of specification (OOS) investigation.
Attendees will leave with a clear understanding of how to improve processes in their laboratory and how those improved processes can lead to a more compliant product.