Negotiating An FDA Import Hold CrisisStrategies for Challenging FDA Findings

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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.

A shipment of critical materials is en route from your supplier in India. 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. 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 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?

Mark your calendar for Wednesday, May 11, when you’ll discover the answers — and more — in the intensive webinar, Negotiating an FDA Import Hold Crisis, conducted by a leading imports lawyer and former FDA official, Benjamin L. England.

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

Last December, the Los Angeles FDA office inaugurated the PREDICT system to review imports. Just weeks ago, the CDRH warned importers to tighten up procedures on import information verification. Now, it’s the U.S. Customs & Border Protection Service. What will be next?

In just 90 fast-paced minutes, Mr. England will cover what you need to know about getting your imports landed, safe and sound, and without delays. Here’s just a sampling of what he’ll cover:

  • How to analyze and understand a Notice of FDA Action and plan a response
  • Strategies for challenging FDA findings — 5 that succeed, 5 to avoid
  • 6 techniques for communicating clearly and quickly with FDA personnel
  • Understanding and complying with documentation requirements
  • Levels of import holds and likelihood of successful challenges at each
  • Import alerts — how to prevent your shipments getting the death penalty, and what to do if it’s imposed
  • How the PREDICT system will influence the import alert and hold process
  • Making sure your PREDICT profile doesn’t raise red flags with the FDA
  • And much more

Negotiating an FDA Import Hold Crisis is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you work at the office or telecommute from your office at home.

Of course, Mr. England will be on hand to answer all of your questions. Simply submit them via email, and you’ll have answers by the time the session ends.

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.

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

Benjamin L. England Esq., Benjamin L. England & Associates LLC, focuses his legal practice on FDA matters. During a 17-year FDA career, he served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs, guiding responses to FDA and USDA. As a private practitioner, he assists FDA-regulated clients leveraging risk management programs for food, medical device or drug distribution against FDA and Customs import clearance processes. He is a member of the Association of Food and Drug Officials (AFDO) and the Bars of Florida, Maryland, and the District of Columbia.

Register now!

Date: May 16 – June 3, 2011
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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