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UID:2140535:Event:63130
DTSTAMP:20260518T233914Z
SUMMARY:FDA's New Import Program Concerning International Consequences
 : 2-day In-person Seminar
DESCRIPTION:Course Description:\nImporting products regulated by the F
 DA has become more complicated. The FDA is using increasingly strict c
 riteria. In order to ensure that your imported product does not get de
 tained or refused entry, you should be knowledgeable about FDA require
 ments for foods, medicines, medical devices, cosmetics and radiation e
 mitting devices. In addition, there are import requirements that are e
 nforced by U.S. Customs and Border Protection (CBP) and intersect with
  the FDA’s legal requirements.\nWhen products are detained, the situ
 ation 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 destr
 oyed at your expense. The FDA’s use of automatic detention procedure
 s makes it increasingly difficult to conduct an import business. A for
 eign manufacturer may receive a “Warning Letter” from the FDA or a
 n 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 r
 elated to product detentions and how to deal with it, how US customs l
 aws and FDA laws intersect etc. is critical to a firm’s successful i
 mport business and help reducing the commercial disadvantages it creat
 es.\nWith what you learn in this seminar, you can work more productive
 ly and mitigate the risk of FDA detention. A high-ranking ex-FDA insid
 er 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 pr
 event problems in the first place.\n\nLearning Objectives:\n\nProvide 
 clarity to the FDA import program and process;\nUnderstand how U.S. Cu
 stoms and FDA laws intersect;\nKnow how to manage foreign suppliers th
 at make the products;\nUnderstand the internal procedures the FDA foll
 ows for imported products;\nUnderstand how and with whom to negotiate 
 at the FDA;\nLearn how you can mitigate the cost and risk of detention
 ;\nLearn how to avoid common and costly problems;\nDevelop practical w
 ays to improve your import and export business;\nIdentify government p
 rograms designed to help;\n\n\nWho will Benefit:\nThe FDA’s regulato
 ry 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 e
 xpensive consequences if they do not plan carefully. Attendees need to
  understand the FDA’s and the US Customs Border Patrol’s regulator
 y criteria, inter-agency agreements and intra-agency procedures. The c
 onference provides attendees with the opportunity to understand their 
 work’s inter-relationship with other attendees’ roles.\n\nBusiness
  Planning Executives\nRegulatory Managers\nIn-house Legal Counsel and 
 Contract Specialists\nVenture Capitalists\nBusiness Acquisition Execut
 ives\nOwners of New or Developing Import/Export Firms\nInternational T
 rade Managers\nImport Brokers\nInvestors\nLogistics Managers\nSales Ma
 nagers\n\n\nFor more information visit https://medtechiq.ning.com/even
 ts/fda-s-new-import-program-concerning-international-consequences-2
DTSTART;TZID=America/New_York:20140320T083000
DTEND;TZID=America/New_York:20140321T163000
CATEGORIES:life, science
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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