2 Day Course: Tougher Import Rules for FDA Imports in 2018 (Boston, MA - September 13-14, 2018) - ResearchAndMarkets.com

May 15, 2018

DUBLIN--(BUSINESS WIRE)--May 15, 2018--The “Tougher Import Rules for FDA Imports in 2018” conference has been added to ResearchAndMarkets.com’s offering.

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. CBP is implemented a new “Automated Commercial Environment” computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port.

When products are refused, you have different options. Some options may cost more than others. For example, your product can be seized and 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.

Learn how to deal with common problems, such as returns for repair, importing QC samples, and investigational products.

On a positive note, the FDA is implementing the Voluntary Qualification Importer Program under the FDA Food Safety and Modernization Act. One other perk is that FDA offers export certificates, for a modest fee, which may give you a competitive advantage in foreign markets. In some cases, a FDA export certificate is required by foreign governments. Finally, the new EU Medical Device Regulation will change how FDA manages foreign inspections and in your favor.


Day 1 Schedule

Lecture 1: FDA Legal Authority Customs and Border Control (CBP) Import Process FDA Import Process Registration and documentation Lecture 2: FDA Import Process (continued) Import BrokersPrior Notice InformationCBP and FDA computer programsImport CodesBonds and Bonded WarehousesFDA “Notice of Action” Lecture 3: Import Delays Import Alerts Detention Refusals

Day 2 Schedule

Lecture 1: Foreign Inspections FDA 483 - Inspectional Observations Lecture 2: FDA Warning Letters and Automatic detention Lecture 3: Import Hypothetical FDA Import for Export Program FDA Export Program Export Hypothetical Lecture 4: FDA Export Program Special Import Issues Trade ShowsPersonal UseCompassionate Use

For more information about this conference visit https://www.researchandmarkets.com/research/crfd2t/2_day_course?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20180515005846/en/

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Related Topics:Pharmaceuticals,Medical Devices



SOURCE: Research and Markets

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PUB: 05/15/2018 07:59 AM/DISC: 05/15/2018 07:59 AM


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