Every FDA-regulated manufacturer that imports goods and materials is facing a new threat – a get-tough crackdown on adulterated or misbranded materials. Worried that your shipment could end up stuck at the pier? You should be. Here’s how to overcome this latest FDA compliance challenge. Register for the “virtual conference:” FDA Import Holds: Black Hole or Bright Spot for Managing Your Imports? being held on Wednesday, February 29.
A shipment of critical materials is en route from your supplier in China. Your customers are demanding that you fill orders. Your factory floor staff is going nuts. But guess what? Your product has been impounded on the dock. U.S. Customs and the FDA won’t let you bring it in.
Welcome to the new world of “Import Alerts.” As if you don’t have enough to do keeping the FDA happy, now you have another agency to deal with. The U.S. Customs & Border Protection Service has the power to stop your shipments — raw materials, APIs or finished products, drugs or devices — from entering the country. It needs no court order or authorization; it can act virtually at will.
It cares little that your shipment may be perishable and deteriorating by the minute. If in Customs’ or the FDA’s opinions the shipment is adulterated or misbranded, or the supplier had previous problems, it can stop matters cold.
Who do you call? What do you say? What is your recourse? Clear your calendar for Wednesday, February 29, when you’ll hear from top experts in an intensive “virtual conference,” FDA Import Holds: Black Hole or Bright Spot for Managing Your Imports?
A Day of Learning
It’s a Virtual Conference, sponsored by FDAnews and featuring 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 firms that deal with overseas suppliers, this session couldn’t be timelier.
In addition to the eyes and ears of the Customs department, the FDA’s new data mining PREDICT system to review imports is up and running around the country. The FDA is warning importers to tighten up procedures on import information verification now.
In just one fast-paced day, you’ll learn how to avoid import hold-related problems and assure speedy delivery. Here’s just a sampling of what will be covered:
Why voluntary data (i.e. Affirmations of Compliance) becomes more important — and practically, less voluntary
Best practices to assure your PREDICT profile doesn’t raise red flags with the FDA
How the PREDICT system will influence the import alert and hold process
Details on the Advocate for Qualified Trusted Import Program (QTIP)
Best practices for achieving pre-admission decisions prior to reaching the border
What steps within the FDA's "Pathway to Global Product Safety and Quality" initiative apply to importation procedures
What are the most common problems with labeling that raises red flags for Customs and FDA staff
5 steps you can take to reduce any appearance of violation
Here’s How It Works
FDA Import Holds: Black Hole or Bright Spot for Managing Your Imports? is convenient to attend. All that’s required is that your team be in front of a screen at the appointed time.
Twenty-four hours prior to Virtual Conference Wednesday, attendees will receive all presentations. Then just log on to the Virtual Conference website and dial a toll-free number, both provided in your registration confirmation. And relax. That’s all there is to it.
Key people throughout your company will benefit from taking part in this event. Best of all, everyone can do so at a cost that won’t break the budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.
The subjective nature of import holds means you may have a different experience at Entry Point A than at Entry Point B, C, or D. If your shipment lands on a day when an inexperienced Customs or FDA person is in charge, it could be a very bad day indeed. Don’t take unnecessary risks. Sign up today for this timely learning event.
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:
Supply chain managers
Consultants/service providers involved in imports
Manufacturing directors and supervisors to the extent manufacturing aspects involve imported material
Regulatory/legislative affairs professionals
Date: Wednesday, Feb. 29, 2012
Location: Your office or conference room (no need to travel!)
Time: 10:00 a.m. – 4:00 p.m. EST
9:00 a.m. – 3:00 p.m. CST
8:00 a.m. – 2:00 p.m. MST
7:00 a.m. – 1:00 p.m. PST
3:00 p.m. – 9:00 p.m. GMT