How to Survive Import Alerts and PREDICT – FDA’s New Import Screening Program | November 7, 2013, 2 PM EDT| England |

How to Survive Import Alerts and PREDICT – FDA’s New Import Screening Program | November 7, 2013, 2 PM EDT| England |

March 13th, 2013 // 1:06 pm @

predict


Feedback from our recent 2013 Webinar: “Thank you – the Webinar was extremely informative.” “Benjamin is a wonderful speaker and our team learned a lot today.” “Our staff really appreciated all of the great information the speaker related today.”

The FDA’s PREDICT system has DRASTICALLY changed how FDA screens your drugs and devices that arrive at US ports. And it is causing a great deal of confusion and questions in the pharmaceutical industry.

Background on FDA PREDICT System

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, this is all different. This new system is wonderful for companies that understand its intricacies and how to work the system to your best advantage.

But it is a headache for companies that are not familiar with PREDICT and try do business as they did before.
PREDICT lets 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 reviews your drugs or medical devices, it will assess the following:

  • The risks that are in the product, such as its potential harm to patients and how likely it is to be adulterated
  • Past FDA audit results, both foreign and US, related to the product
  • Sample analyses data and results from earlier product entries, and
  • News and other accounts of problems with your products

So, under PREDICT, you must keep your company’s profile as clean as possible so you are not flagged in the new screening system. For companies with a clean record, PREDICT will result in faster import clearances.

But, if you don’t understand PREDICT, you won’t be able to take advantage of it. The best thing you can do to prevent big delays later on?

Register for an information-packed Webinar with the industry expert in drug/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.

What You Will Learn in this FDA PREDICT System Webinar

In this 90 minute session, England will cover it all so that you and your team are totally knowledgeable with PREDICT. Learn:

  • 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

About the Speaker

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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