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    "Understanding FDA Import Alerts"

    View: 310

    Website https://compliance2go.com/product/?pid=CP2014-330 | Want to Edit it Edit Freely

    Category Biotechnology , Medical Device , Pharmaceutical

    Deadline: September 07, 2014 | Date: September 07, 2014

    Venue/Country: ?10777 Westheimer Suite 1100, Houston, Texas, USA,, U.S.A

    Updated: 2014-06-17 15:30:09 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    An Import Alert allows FDA to detain, without physical examination, products that either have or potentially could violate the Food, Drug, and Cosmetic Act (“FDC Act”). Import Alerts lets FDA Field Staff know that the agency has enough evidence or other information to refuse admission of future shipments of an imported article. There are a variety of factors that could lead FDA to place a product, manufacturer, shipper, grower, geographical area, and/or country on Import Alert.

    Once a shipment is refused admission to the U.S., the importer has an opportunity to introduce evidence, within 10 days, to overcome the appearance of a violation. During this time, the product is either held at a warehouse or at the importer’s premises and cannot be distributed. If the shipment is not proven to be safe, it must be destroyed or exported within 90 days.

    This webinar will provide attendees with background about FDA Import Alerts, examine why they are issues, where to locate them, how to find whether a company or product is the subject of an Import Alert, and finally, provide a series of strategic recommendations for getting off of an Alert.

    Learning objectives:

    - Understand the nature of Import Alerts: What are they? What purpose do they serve? What do they mean for a company?

    - Become familiar with CBP and FDA’s shared jurisdiction at U.S. ports.

    - Company or Products to be added to an Import Alert.

    - Be able to find and search FDA’s Database of Import Alerts.

    - Understand the potential and real impact of being named on an FDA Import Alert.

    - Be able to identify the steps for removing a Company or Product from an Import Alert.

    - What to do if you learn that your products are being detained by FDA at a port and your Company’s name is added to an Import Alert.

    Areas covered in this webinar:

    ?

    - Import Alerts

    - The different types of Import Alert issued by FDA

    - What Causes a Country, Company or Products to be added to an Import Alert

    - What impact does being named on an Import Alert have on a Company

    - What to do if your products are Held or Detained at the port by FDA.

    - What to do if your Company or Products are named on an Import Alert.

    - Strategic Recommendations for removing one’s Company and/or Products from an Import Alert.

    Who will benefit:

    Regulatory Affairs Professionals, Managers, Consultants, Scientists, Research Analysts, State Policy Officials, Insurers focusing on Representations & Warranties Insurance; Investment Analysts; Venture Capitalists.

    Pharmaceutical, Biologics, Animal Health, Food, Medical Device and other Biotech Companies

    Domestic and Foreign Corporations, Small Business, Start-Up Ventures, Manufacturers, Importers, Labelers and Product Distributors

    Importers, Customs Brokers, Distributors

    Financial analysts and investors watching the pharmaceutical, life sciences and biotech industries

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    PDF print only copy of PowerPoint slides

    90 Minutes Live Presentation

    Certificate of Attendance


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.