Training Course Syllabus:
In 2010, FDA published the final rule governing import of all dietary supplements into the US. This rule consolidated the previous rules for GMP, documentation, packaging and labeling, ingredient testing, and adverse event reporting requirements. The rules describe in detail the import and marketing requirements for all dietary supplements prior to importing into the country or getting into the US market, if manufactured domestically. Additional requirements such as Foreign Supplier Verification Program (FSVP) and third-party audit program have been proposed to further regulate the import of dietary supplements into the US.
This webinar will provide practical instructions to meet the current requirements in the process of manufacture and import of dietary supplements including description of key terms, concepts, and common issues that dietary supplement manufacturers are likely to encounter.
Why Should you Attend:
This webinar is intended for manufacturers and importers of dietary supplements who wish to have a better understanding of how FDA regulates dietary supplements and the custom clearance requirements for such products. Attendees will be introduced to the various rules that apply to dietary supplements and how to navigate the Customs entry process. Attending this training will help you to better manage your import compliance activities and help support your logistics supply chain.
Objectives of the Presentation:
The objectives of the presentation are to learn about the:
- Current rules of dietary supplement new ingredients
- Documentation and labeling requirements
- Facility registration for manufacturing sites
- Import and domestic field exams
- Import investigations and sampling
- Role of US import agent
- Dealing with refusal to entry or delay in entry hold