Training Course Syllabus:

Objectives of the Presentation

What are the importing filing processes?
What are the FDA agencies responsible for overseeing import?
How are the FDA-Regulated Product procedures used within the importation process?
What are the customs requirements?
Why are the administrative forms used in the importation process?
How to complete the general certificate of compliance and certification of conformity documentation in the importing process
Complying with customs regulations: Why is it considered a valuable assessment tool for the FDA Regulatory process?

Why Should you Attend

Join expert speaker Dr. Rossano V Gerald in this session that provides guidance on how to access FDA agency documentation addressing the strict requirements of imports of goods for health and safety reasons. These regulatory requirements may have an effect on the importer when it comes to the variety of product ingredients. For example, it will address the agricultural commodities and Food, Drugs and Cosmetics that may be marked as adulterated, mislabeled or misbranded by using procedural examples and cases. This webinar will also provide importers of FDA-regulated goods with guidance on U.S. Customer Border Protection regulations for international logistic transactions.

Areas Covered

Review the role of the import managers when shipping goods under the FDA and customs regulations
How the regulations can be used to help the importer in understanding FDA guidelines in accordance with U.S. Port of Entry requirements in developed and developing markets
FDA procedures and evaluation criterion that will have an effect on the logistics transactions of your company
The classification and valuation of the FDA goods for importing purposes within their dutiable status
What are the proper documentation procedures to meet the country of origin requirements?
Does your FDA import documentation meet foreign law requirements?

Who will Benefit

U.S. importers of FDA regulated products, New U.S. importers of FDA regulated products, Foreign exporters of FDA regulated products(companies which sell regulated products to U.S. importers)Purchasing department personnel for U.S. importers of FDA regulated products, Compliance officers, Logistics/Supply chain managers and analysts, Trade regulatory/legislative affairs professionals, Sales/marketing personnel, Training personnel, Consultants, International business operations, Chief Executive Officers, Customs or Trade Compliance Personnel or Officers, Import or Global Trade Directors or Managers, Import Supervisors

Seminar Summary:

Foreign firms that manufacture medical devices and/or products that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories. In order to import medical devices and/or products into the U.S., the product must meet FDA regulatory requirements. FDA does not recognize regulatory approvals from other countries. These requirements include registration of establishment, listing of devices, manufacturing in accordance with the quality system regulation and medical device reporting of adverse events. (see full course description)

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