FDA Import Holds Virtual Conference Agenda

FDA Import Holds
Black Hole or Bright Spot for Managing Your Imports?
An FDAnews Virtual Conference
Wednesday, Feb. 29, 2012 • 10:00 a.m. – 4:00 p.m. EST

10:00 a.m. – 10:15 a.m.

Introduction to the Virtual Conference

10:15 a.m. – 11:15 a.m.

The New Enforcement Posture: PREDICT, Customs and 2012 FDA Trends
Get the inside track on the emerging powers of FDA for enforcement, screening and Inspections in light of new legislation and trends. Understand the impact of PREDICT, risk data, statistics and processes and the trends affecting manufacturers, importers and distributors this year. Understand the trends, understand the FDA, and solidify your strategies.

Attendees will learn:

  • What is PREDICT and how does it affect me?
  • FDA's importation authorities and processes — what’s changing and what’s staying the same
  • What trends are the FDA and Customs focusing on today that could get you in hot water
  • Understanding the thresholds and severity of the new enforcement powers at play

11:15 a.m. – 11:30 a.m.

Break

11:30 a.m. – 12:30 p.m.

Certified Importer Approach: Better Than Transactional Controls —Assessing the Potential for Integrated Border Management Between FDA, Customs and USDA
Currently the FDA, Customs and USDA operate independently of each other with regards to approving goods into the U.S. This process is very complex and is subjected to each import transaction which can cause undue delays at the border. An integrated border management framework, where the various agencies work in concert with each other, can allow a drug to be pre-approved for distribution and help to streamline the process of crossing the border. A promising initiative, the Qualified Trusted Importer Program (QTIP), would assess a company’s internal processes and controls with respect to product quality, supply chain security and trade compliance. Upon review, companies that qualify as “trusted importers” would be afforded interagency green lane status. Not only would this allow a company to receive a pre-admission decision from the FDA, Customs and USDA, but it would also prevent a company from having to go through a lengthy process for each transaction. For a company that imports on a large scale, it would be a significant savings of time and resources. This session discusses the potential benefits of an integrated border management program.

Attendees will learn:

  • How to apply risk management techniques to ensure compliance
  • Details on the Advocate for Qualified Trusted Import Program (QTIP)
  • Benefits of an account management rather than transaction system
  • What’s “green lane” status
  • Best practices for achieving pre-admission decisions prior to reaching border

12:30 p.m. – 1:30 p.m.

Lunch

1:30 p.m. – 2:30 p.m.

Global Supply Chains and Importation:  Where Will The FDA’s New "Pathway" Initiative Take Us?
In 2011 the FDA unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain.  One of the tools available to the FDA is the use of the import alert/hold.  This presentation will describe how the FDA uses this authority and how industry and the FDA can work together to assure global imports are more effectively managed.

Attendee will learn:

  • What steps within the FDA's "Pathway to Global Product Safety and Quality" initiative apply to importation procedures
  • Best practices industry can take to assure compliance with registration and importation requirements
  • What's next on the horizon regarding global supplier management?

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 3:45 p.m.

How to Review Product Labeling To Avoid FDA Import Compliance Woes — 5 Steps You Need to Take
Incorrect or confusing labeling is a key reason why many products face import holds.  The authority to hold product is based upon the “appearance” of a violation so proper labeling is critically important.  This presentation will help firms understand that no matter what the product is (API, OEM, finished goods) or who it’s being imported from (partner, sister company, supplier) the labeling needs to be accurate to assure smooth entry.

Attendees will learn:

  • 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

3:45 p.m. – 4:00 p.m.

Closing Comments and Adjournment