Surviving the FDA’s New PREDICT Import Screening Program National Rollout Nearly Complete — Impact Already in Effect

Held Sept. 28, 2011

The FDA’s PREDICT system is dramatically changing the way the agency screens drugs and medical devices arriving in the US.

For years, the FDA relied largely on entry document review and intuition in deciding which imports to detain for testing and scrutiny and which to let pass without review.

With PREDICT, that’s all changing. This new system is great news for those companies that understand how it works and take advantage of its new features.

But it will be big trouble for those companies that do business the same old way.

The PREDICT system allows the FDA to take into consideration a whole array of new information to determine whether to examine a shipment – information that was not generally available to its inspectors before.

Now, when the agency looks at a shipment of your drugs or medical devices, it will be assessing:

  • The risks inherent in the product, such as its potential harm to patients and susceptibility to adulteration
  • Past inspection results, both foreign and US, related to the product
  • Results of sample analyses from previous product entries, and
  • News and informal accounts of problems with your products

All of this additional information will help the agency make the most of its inspections by targeting problem products.

So, from now on, you’ll need to keep your company’s profile as clean as possible so you aren’t needlessly caught up in the new screening filter. For companies with a good track record, PREDICT will result in faster import clearances.

But, if you don’t understand which practices can disrupt PREDICT, you won’t be able to take advantage of it.

The best thing you can do to prevent big delays later on? Attend this FDAnews webinar now to
learn how to make the PREDICT system work for you in the future.

Sign up now for an intensive learning session with the “guru” of drug and device importation, Benjamin England Esq. Following a 17-year career as an FDA legal officer, Mr. England has helped drug and device manufacturers negotiate the release of dozens of FDA-regulated shipments into the U.S.

In this session you’ll learn how PREDICT works and how to institute best practices to improve supply chain and import procedures.

In 90 fast-paced minutes, you’ll go from the basics of PREDICT to compliance mastery. Here’s just a smattering of what we’ll cover:

  • History of PREDICT and current roll-out status
  • Why voluntary data (i.e. Affirmations of Compliance) becomes more important
  • Toughened enforcement of proper registration and listing data
  • Assuring your PREDICT profile doesn’t raise red flags with the FDA
  • How the PREDICT system will influence the import alert and hold process
  • How the Food Safety Modernization Act may affect drugs and devices:
    • Foreign Supplier Verification
    • Mandatory Recall (drugs)
    • Qualified Importer Program
    • Foreign Inspection Targets
  • And much more

Everyone in your organization with a role in PREDICT deserves to take part in this event — and they can, at a cost that won’t break the budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.

This is a workshop you attend without leaving your workplace. Simply make sure you’re in front of a screen at the appointed time. Have questions? Submit them via email for answers by the time the session ends.

FDA scrutiny of offshore suppliers is intensifying. It’s high time you structured your supply-chain programs for maximum effectiveness under PREDICT. Register now for this super-timely learning experience.

Spread the word throughout your organization. Make particularly sure to notify the following key staff:

  • Executive management
  • Supply chain managers
  • Compliance officers
  • 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

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Benjamin L. England Esq. is founding member of Benjamin L. England & Associates LLC.  During a 17-year FDA career, he served as Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. In private practice, he guides clients facing FDA and USDA inspection and enforcement actions, as well as FDA and Customs criminal investigations, inquiries and prosecutions; and helps clients leverage risk management programs for food, medical device or drug distribution against FDA and Customs import clearance processes.

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