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Last updated on April 18, 2014 at 8:42 EDT

Import Holds: What Happens in the First Five Days Equals Success or Failure

September 4, 2013

FALLS CHURCH, Va., Sept. 4, 2013 /PRNewswire-iReach/ — FDA Import Holds

New Powers to Control Products

**FDAnews Virtual Conference**

Sept. 24, 2013 — 10:00 a.m. – 4:00 p.m. EDT

www.fdanews.com/FDAImportHoldsVC

(Photo: http://photos.prnewswire.com/prnh/20130904/MN73975)

The FDA has a new weapon in its arsenal — the ability to detain for up to 20 days drug products it believes are adulterated or misbranded, in addition to its existing import hold powers. And, it’s working closer than ever with Customs and Border Protection and the USDA to stop bad shipments.

Customs officials don’t care that your shipment may be perishable and deteriorating by the minute. If the supplier has been tagged in the PREDICT system the product has been identified as adulterated, your shipment can be stopped cold.

To bring you up to date on these new powers, the status of the PREDICT system, the new PLAIR guidance and the proposed Qualified Trusted Importer Program, FDAnews has brought together a top-notch team to teach you the following:

Best practices for getting pre-admission decision before your product reaches the border:

    --  What the most common problems are with labeling
    --  Details on the Qualified Trusted Import program
    --  How the PREDICT system has been working post-rollout and
    --  Six ways to best communicate with FDA staff to keep your shipment moving
        towards its delivery goal

Register Today

In just one fast-paced day, you’ll hear from…

    --  Casper Uldriks, Counsel, Olsson Frank Weeda Law; former Associate
        Director for Regulatory Guidance and Government Affairs, CDRH (invited).
        Casper spent 30 years at the FDA and is one of the nation's top experts
        on import holds and supplier management issues.
    --  Michael Mullen, Executive Director, Express Association of America.
        Mike frequently meets with FDA officials to help improve importation
        issues.  Most recently, he met with Melinda Plaiser, Acting Associate
        Commissioner, regarding recommendations on FDA import entry
        admissibility decisions.
    --  William Nychis, Senior Regulatory Advisor, FDAimports.com.  William has
        nearly 40 years of experience at FDA.  He drafted numerous guidance
        documents, import alerts and policy documents for FDA.
    --  Jim Johnson, Pharmaceutical and Life Sciences Group, Hogan Lovells;
        formerly Associate Chief Counsel, Office of the Chief Counsel, FDA.  Jim
        has been on both sides of import holds - enforcing them on behalf of the
        FDA and successfully getting clients' products released from them.

This virtual conference, sponsored by FDAnews, features top experts who have been in the import holds trenches. Without ever leaving the comfort of your office, you’ll gain practical knowledge that helps you assure your valuable product makes it from supplier to your loading dock without problems.

For drug, device, biologics and diagnostics companies that deal with overseas suppliers, this conference couldn’t be timelier.

FDA Import Holds: New Powers to Control Products is convenient to attend. All that’s required is that your team be in front of a screen at the appointed time. Register today.

Who Will Benefit

Drug, device, biologics or diagnostics, every FDA-regulated company that deals with offshore importers is a candidate for participation. It’s ideal for:

    --  Compliance officers
    --  Executive management
    --  Supply chain managers
    --  Warehouse/shipping managers/supervisors
    --  Consultants/service providers involved in imports
    --  General/corporate counsel
    --  Manufacturing directors and supervisors to the extent manufacturing
        aspects involve imported material
    --  Regulatory/legislative affairs professionals

Conference Details

FDA Import Holds

New Powers to Control Products

**FDAnews Virtual Conference**

Sept. 24, 2013 — 10:00 a.m. – 4:00 p.m. EDT

www.fdanews.com/FDAImportHoldsVC

Tuition

$1,297 per site — includes virtual conference registration and audio cds and transcripts

4 Easy Ways to Register

Online: www.fdanews.com/FDAImportHoldsVC

By phone: 888-838-5578 or 703-538-7600

Fax: 703-538-7676

Mail to: FDAnews

300 N Washington St

Ste 200

Falls Church VA USA 22046-3431

Media Contact: Jeff Grizzel, FDAnews, 703-538-7600, jgrizzel@fdanews.com

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SOURCE FDAnews


Source: PR Newswire