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Overview: FDA's and the Customs and Border Patrol Service (CBP) has become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. A number of factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities. Why should you attend? What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing. The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. What happens when FDA decides you should bring the products back to the port of entry after you received a release but you cannot locate the product that has been sold? CBP may fine you three times the value of the shipment. FDA may have other adverse legal concerns and strategies. When products are refused, you have different options. Some options may cost more than others. For example, your product may be destroyed by the government. You may be fined if you do not act in a timely manner. These are common problems that become prohibitively expensive. You should know how to avoid common problems or at least how to mitigate the cost by using established and effective business planning. Course Outline: Day 1 - June 12th 2014 9:00 AM - 10:30 AM • FDA Import History and Legal Authority • Customs and Border Control (CBP) Import Process • FDA Import Process 10:30 AM - 10:45 AM Break 10:45 AM - 12:00 PM • FDA Import Process (continued) o Import Brokers o Prior Notice Information 12:00 PM - 1:00 PM Lunch 1:00 PM - 2:45 PM • FDA Import Process (continued) o Import Codes o Bonds and Bonded Warehouses o FDA "Notice of Action" 2:45 PM - 3:00 PM Break 3:00 PM - 5:00 PM • Import Detention ( 5 Minute Break ) • Import Delays • Import Alerts Day 2 - June 13th, 2014 9:00 AM - 10:30 AM • Foreign Inspections • FDA 483 - Inspectional Observations 10:30 AM - 12:00 PM FDA Warning Letters 12:00 PM - 1:00 PM Lunch 1:00 PM - 2:45 PM • Import Hypothetical • FDA Import for Export Program • FDA Export Program • Export Hypothetical 2:45 PM - 3:00 PM Break 3:00 PM - 5:00 PM • FDA Export Program ( 5 Minute Break ) • Special Import Issues o Trade Shows o Personal Use o Compassionate Use Who Will Benefit: • Domestic importers • Foreign exporter • Initial importers • International trade executives • Venture Capitalists • Marine insurance underwriters • Import Brokers • Regulatory affairs managers • Import / Export consultants • In-house counsel • Contract specialists • Logistics managers • Third party establishment inspection entities • Sales managers • Investors About Speaker: Casper Uldriks Ex-FDA Expert and former Associate Center Director of CDRH, Olsson Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straight forward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap now works almost exclusively on medical device issues at Olsson, Frank and Weeda (OFW Law in Washington, D.C. DATE, VENUE & PRICE: Location: Washington, DC Date: June 12th & 13th, 2014 Time: 9 AM to 5 PM Venue: WILL BE ANNOUNCED SOON Price: $1,295.00 Register now and save $200. (Early Bird) Until May 20, Early Bird Price: $1,295.00 From May 21 to June 10, Regular Price: $1,495.00 Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php Event Link - http://bit.ly/1j6xerK GlobalCompliancePanel Net Zealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
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