In 2010, FDA published the final rule governing importing 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 great details the import and marketing requirements for all dietary supplements prior to import into the country or getting into 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.
Get insights straight from regulatory affairs and quality assurance expert Dr. Mukesh Kumar as he provides practical instructions to meet the current requirements in the process of manufacture and import of dietary supplements in the U.S. The audio session will also cover description of key terms, concepts, and common issues that dietary supplement manufacturers are likely to encounter.
This seminar 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.
Who should attend:
Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...
More Events By The Speaker