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DTSTAMP:20260509T100614Z
SUMMARY:FDA's New Import Program Concerning International Consequences
 : 2-day In-person Seminar
DESCRIPTION:Course Description: Importing products regulated by the FD
 A has become more complicated. The FDA is using increasingly strict cr
 iteria. In order to ensure that your imported product does not get det
 ained or refused entry, you should be knowledgeable about FDA requirem
 ents for foods, medicines, medical devices, cosmetics and radiation em
 itting devices. In addition, there are import requirements that are en
 forced by U.S. Customs and Border Protection (CBP) and intersect with 
 the FDA’s legal requirements. When products are detained, the situat
 ion becomes a very costly problem, and a firm needs to know what its o
 ptions are and how it will resolve the detention quickly. Detentions c
 an hold up a product for months only to have it re-exported or destroy
 ed at your expense. The FDA’s use of automatic detention procedures 
 makes it increasingly difficult to conduct an import business. A forei
 gn manufacturer may receive a “Warning Letter” from the FDA or an 
 inspectional “483.” You need to know how a FDA regulatory action a
 ffects your import business and what to do before that action dries up
  your import pipeline. Understanding all of these and other issues rel
 ated to product detentions and how to deal with it, how US customs law
 s and FDA laws intersect etc. is critical to a firm’s successful imp
 ort 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 min
 dset. You will learn practical information, such as how to interact wi
 th FDA, the options you have to resolve problems and how you can preve
 nt problems in the first place. Learning Objectives: Provide clarity t
 o 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 impo
 rted products; Understand how and with whom to negotiate at the FDA; L
 earn how you can mitigate the cost and risk of detention; Learn how to
  avoid common and costly problems; Develop practical ways to improve y
 our 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 import
 ers 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 atten
 dees with the opportunity to understand their work’s inter-relations
 hip with other attendees’ roles. Business Planning Executives Regula
 tory Managers In-house Legal Counsel and Contract Specialists Venture 
 Capitalists Business Acquisition Executives Owners of New or Developin
 g Import/Export Firms International Trade Managers Import Brokers Inve
 stors Logistics Managers Sales Managers\n\nFor more information visit 
 https://medtechiq.ning.com/events/fda-s-new-import-program-concerning-
 international-consequences-1
DTSTART;TZID=America/New_York:20140306T180000
DTEND;TZID=America/New_York:20140306T190000
CATEGORIES:biotechnology, and, pharmaceutical
LOCATION:Orlando Airport Marriott
WEBSITE:http://www.complianceonline.com/ecommerce/control/seminar?prod
 uct_id=80133SEM&?channel=medtechiq
URL:http://www.complianceonline.com/ecommerce/control/seminar?product_
 id=80133SEM&?channel=medtechiq
CONTACT:+1-650-620-3915
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
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 file/get/2562006613?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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