FDA's New Import Program Concerning International Consequences: 2-day In-person Seminar

Course Description: Importing products regulated by the FDA has become more complicated. The FDA is using increasingly strict criteria. In order to ensure that your imported product does not get detained or refused entry, you should be knowledgeable about FDA requirements for foods, medicines, medical devices, cosmetics and radiation emitting devices. In addition, there are import requirements that are enforced by U.S. Customs and Border Protection (CBP) and intersect with the FDA’s legal requirements. When products are detained, the situation becomes a very costly problem, and a firm needs to know what its options are and how it will resolve the detention quickly. Detentions can hold up a product for months only to have it re-exported or destroyed at your expense. The FDA’s use of automatic detention procedures makes it increasingly difficult to conduct an import business. A foreign manufacturer may receive a “Warning Letter” from the FDA or an inspectional “483.” You need to know how a FDA regulatory action affects your import business and what to do before that action dries up your import pipeline. Understanding all of these and other issues related to product detentions and how to deal with it, how US customs laws and FDA laws intersect etc. is critical to a firm’s successful import business and help reducing the commercial disadvantages it creates. With what you learn in this seminar, you can work more productively and mitigate the risk of FDA detention. A high-ranking ex-FDA insider will give you straight talk on how FDA operates and the agency’s mindset. You will learn practical information, such as how to interact with FDA, the options you have to resolve problems and how you can prevent problems in the first place. Learning Objectives: Provide clarity to the FDA import program and process; Understand how U.S. Customs and FDA laws intersect; Know how to manage foreign suppliers that make the products; Understand the internal procedures the FDA follows for imported products; Understand how and with whom to negotiate at the FDA; Learn how you can mitigate the cost and risk of detention; Learn how to avoid common and costly problems; Develop practical ways to improve your import and export business; Identify government programs designed to help Who will Benefit: The FDA’s regulatory controls for imported and exported devices have become increasingly pervasive and stringent. Foreign manufacturers, foreign exporters and domestic initial importers face greater scrutiny and are subject to expensive consequences if they do not plan carefully. Attendees need to understand the FDA’s and the US Customs Border Patrol’s regulatory criteria, inter-agency agreements and intra-agency procedures. The conference provides attendees with the opportunity to understand their work’s inter-relationship with other attendees’ roles. Business Planning Executives Regulatory Managers In-house Legal Counsel and Contract Specialists Venture Capitalists Business Acquisition Executives Owners of New or Developing Import/Export Firms International Trade Managers Import Brokers Investors Logistics Managers Sales Managers