Tougher Import Rules for FDA Imports in 2015
The course offers detailed information about the roles and responsibilities of the various parties involved with an import operation and on how to correct the weakest link in the commercial chain.
Fremont, CA, September 21, 2015 (Newswire.com) - GlobalCompliancePanel announces two-day, in-person, live seminar on the topic, “Tougher Import Rules for FDA Imports in 2015”. Casper Uldriks, ex-FDA Expert and former Associate Center Director of CDRH, Olsson, will be the speaker at this seminar. The course offers detailed information about the roles and responsibilities of the various parties involved with an import operation and on how to correct the weakest link in the commercial chain.
Fremont, CA: GlobalCompliancePanel, a leading provider of regulatory compliance trainings for a wide range of regulated industries, will organize a two-day seminar in Washington, DC on October 1 and 2, 2015. The topic of this seminar is “Tougher Import Rules for FDA Imports in 2015”.
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
About the seminar:
The FDA and the Customs and Border Patrol Service (CBP) have become increasingly agile, sophisticated and demanding when it comes to the submission of information and adherence to government procedures. Firms that do not properly execute an import and export program can have their shipment delayed, detained or refused.
For more information or to register for the seminar, please click here.
What happens when a company’s product is detained? FDA will begin an expensive and time-consuming legal process. It expects companies to have the import coding information accurate and up-to-date. Companies which do not have a clear understanding of the automated and human review process can expect detained shipments. The CBP’s new “Automated Commercial Environment” computer program has made changes to the process of import logistics and information reporting for FDA regulated products. A shipment may be stopped before it is even loaded at the foreign port.
Another challenge importers face is when the FDA decides that they should bring the products back to the port of entry after they received a release but cannot locate the product that has been sold. Such an action attracts a fine that is three times the value of the shipment, apart from carrying other adverse legal concerns and strategies.
This seminar will teach participants the ways by which to avoid these and related common problems that can become prohibitively expensive in the absence of a proper strategy and plan for dealing with. The key to this is using established and effective business planning. The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities.
About the Speaker:
Casper Uldriks is an ex-FDA Expert and former Associate Center Director of CDRH, Olsson.
He served as a senior manager in the Office of Compliance and 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 for FDA.
About GlobalCompliancePanel:
GlobalCompliancePanel is a specialized offering from NetZealous, a Fremont, CA-registered organization. It is a source for a wide range of professional trainings, compliance trainings and consulting for the regulated industries. GCP offers a broad range of high quality regulatory and compliance-related services relating to medical devices, pharmaceutical, FDA, clinical trials, laboratory compliance, biologicals, drugs, food and biotechnology.
GlobalCompliancePanel has many well-known names among its clients. These include Bristol-Myers Squibb, Roche, Merck, Baxter, Johnson and Johnson, Pfizer, Abbot, Boehringer Ingelheim, Bayer, Molina Healthcare, Pfizer, Alcatel-Lucent, American Express, Medtronic, Lonza, Emerson Hospital, GlaxoSmithKline, Novartis and many more.
Over 50,000 professionals in the various areas in which GlobalCompliancePanel offers its trainings have benefited from the vast experience of its well-known speakers, who are reputed globally in their respective fields.
Contact information:
Call: 1-800-447-9407;
www(dot)globalcompliancepanel(dot)com