Globalcompliancepanel Webinar On strategic Importing Of Fda Regulated Products

Description:

When businesses import items such as foods, medical devices and drugs; they have to meet stringent regulatory requirements set out by the FDA. This however, should not deter importers, as complying with importation requirements of the FDA will help them clear their products and allow them to import without hassles.

The aim of this webinar is to enable participants get an idea of what rules to follow when importing these FDA-approved items. Learning to control importation of FDA-regulated products will help to reduce and avoid examination, detention and refusal. If the impact of FDA examinations has to be minimized; importers have to be equipped with simple, but commonsensical techniques. The knowledge of these techniques will help them resolve negative issues relating to importation of FDA-regulated products.

This webinar will help participantsunderstand how to deal with FDA-Customs-Customs Broker communication to speed up the release of their products for introduction into the market. It will also cover all the regulatory steps involved in the importation of FDA regulated products as they apply to FDA and Customs and Border protection at the ports of entry.

Areas covered in the session:

oFDA Import Law

oFDA import regulations

oLogistics

oFDA Examination Process

oFDA Detention Process

oFDA Refusal Process

oFDA Warning Letters

oUntitled Letters

oFDA Hearing Process

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When: January 30, 2013, 10:00 AM PDT | 01:00 PM EDT

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By whom:

Luis Chavarria recently retired from the United States Food and Drug Administration (FDA) after more than 30 years of service. His unique career covered numerous national and international assignments, starting with the position of Consumer Safety Inspector and ending with the position of Assistant Regional Director for Latin America in the Office of the Commissioner.

He worked in numerous offices and held numerous positions such as Consumer Safety Inspector, Consumer Safety Investigator, Supervisory Consumer Safety Investigator, Drug and Device Specialist, Program Analyst and Diplomat. He was the first foreign-based FDA attach in the United States Embassy in Mexico City, representing the FDA in all program areas.

With more than 28 years experience with the FDA Office of Regulatory Affairs, Luis knows how the agency conducts inspections in all program areas and how regulatory actions are developed within the agency and within the court system. He personally conducted numerous inspections and investigations resulting in legal actions by the agency.

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For whom:

The webinar will benefit

oRegulatory Affairs Managers

oPlant Managers

oExport/Import Managers

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Duration:90 minutes

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To enroll for this webinar, contact

webinars@globalcompliancepanel.com

Phone: 800-447-9407

by: GlobalCompliancePanel

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