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Tougher Import Rules for FDA Imports in 2017

Start Date:
Friday, 27 October, 2017
End Date:
Friday, 27 October, 2017 6:00pm
Speciality:
Nephrology, Neurology, Gastroenterology, Immunology, Hepatology, Infectious Disease, Internal Medicine, Gynecology
Website:
http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901098SEMINAR?meetings4docs-October-2017-SEO

Course "Tougher Import Rules for FDA Imports in 2017" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion Overview: Background:FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused.

As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry 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, negotiate with the FDA and offer anecdotal examples of FDA's import program curiosities. Why you should 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. 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 productsOn 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. Who Will Benefit: Domestic importersForeign exporterInitial importersInternational trade executivesVenture CapitalistsMarine insurance underwritersImport BrokersRegulatory affairs managersImport / Export consultantsIn-house counselContract specialistsLogistics managersThird party establishment inspection entitiesSales managersInvestors Agenda: Day 1 Schedule Lecture 1:FDA Legal Authority Customs and Border Control (CBP) Import Process FDA Import Process Registration and documentationLecture 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 ObservationsLecture 2:FDA Warning Letters and Automatic detentionLecture 3:FDA Import HypotheticalLecture 4:FDA Export Program Special Import IssuesTrade ShowsPersonal UseCompassionate Use SpeakerCasper Uldriksex-FDA Expert and former Associate Center Director of CDRH Casper (Cap) Uldriks owns Encore Insight LLC, which provides consulting services on FDA Law.

He 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, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Location: Los Angeles, CA Date: October 26th & 27th, 2017 and Time: 9:00 AM to 6:00 PMVenue: Four Points by Sheraton Los Angeles International Airport 9750 Airport Boulevard, Los Angeles, CA, 90045, United States Price: Register now and save $200. (Early Bird)Price: $1,295.00 (Seminar Fee for One Delegate)Until September 15, Early Bird Price: $1,295.00 From September 15 to October 24, Regular Price: $1,495.00Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Sponsorship Program benefits for "Quality Assurance Auditing for FDA Regulated Industry" seminarAt this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO's of various designations.

Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts.

Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- https://www.globalcompliancepanel.com/control/sponsorship Contact us today! NetZealous LLC DBA GlobalCompliancePaneljohn.robinson@globalcompliancepanel.com support@globalcompliancepanel.com Toll free: +1-800-447-9407Phone: +1-510-584-9661 Website: http://www.globalcompliancepanel.com Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901098SEMINAR?meetings4docs-October-2017-SEO Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/Follow us on Twitter: https://twitter.com/GCPanel Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri","sans-serif";mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}

Location

Four Points by Sheraton Los Angeles International Airport

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

Address:
NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
Phone:
Event Manager
Email:
john.robinson@globalcompliancepanel.com

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