FDA issues about 7 different kinds of export certificates for products intended to be exported from the US to other countries. These certificates are needed by the importing country; without such certificates these products will not be allowed entry into the importing country.
Many companies export not only products marketed in the US, but also products that may not be legally marketed in the US but are allowed in other countries. For exporters of drugs, biologics, medical devices, diagnostics, food, and all other kinds of products or components, it is important to have an understanding of the documentation requirements, application process, and expectations of the FDA and the importing country to avoid delays due to custom clearance. Before FDA can issue an export certificate to a company, it requires detailed compliance documents and other paperwork from the applicant. Incomplete and inaccurate documents are the most common reason for delays and denials of export certificates.
In this webinar, expert speaker Dr. Mukesh Kumar will provide practical instructions in the process of getting export certificates from FDA including description of key terms, concepts, and common issues that exporters of FDA-regulated products are likely to encounter.
Why should you attend?
This seminar is intended for exporters of FDA regulated products or those that sell regulated products to U.S. exporters and wish to have a better understanding of how FDA regulated products are exported from the U.S. You will be introduced to the types of export certificates, conditions under which FDA issues or denies export certificates, legal requirements, fees, and regulatory requirements for export of FDA-regulated products from the US. Attending this training will help you to better manage your export compliance activities and help support your logistics supply chain.
Areas Covered in the Session:
Who should attend:
- Casper E. Uldriks
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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