The FDA and US Customs have special requirements for importing regulated products in the country which could either be finished products for sales in the US or raw material or components imported for use in manufacture in the US. These products could be prescription drugs and biologics, medical devices, over the counter drugs, dietary supplements, cosmetics, or medical foods. Importers are required to provide detailed documentation regarding the compliance status of imported material, the country of origin, export documents from the country of origin, the destination in the US, purpose of the import, registration documents, chain of control, and several other elements. Incomplete, inadequate, or erroneous documents are the most common reason for delays in the release or refusal to enter at the US customs.
This seminar will provide practical instructions in the process of import of FDA-regulated products including description of key terms, concepts, and common issues that importers of FDA-regulated products are likely to encounter.
This seminar is intended for importers of FDA regulated products or those that sell regulated products to U.S. importers and wish to have a better understanding of how FDA regulated products are entered into the U.S. Attendees will be introduced to the Customs entry process, Customs bond requirements for regulated products; HTS classification of regulated products; FDA import product codes; FDA affirmation of compliance numbers and the FDA entry. Attending this training will help you to better manage your import compliance activities and help support your logistics supply chain.
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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...
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