Drug and Device Recalls Summit


Drug and Device
Recalls Summit

Bethesda, MD • April 29-30, 2014

This Event Has Been Cancelled.
For now, this conference is not being rescheduled,
but we will let you know if this changes.

Drug and device recalls increased as much as 28% last year, what some industry observers have called a “recall-o-rama.”

Thoratec, Pfizer, Respironics, Teleflex, Ben Venue, Tandem Diabetes Care and Dr. Reddy’s are just a few of the companies that have been hit.

How can you avoid being next?

Some experts have been concerned there’s too MUCH recall reporting – firms are over-reporting just to be safe. Others charge firms with not acting fast enough. It’s clear there’s serious confusion among drug and device makers.

Drug and Device Recalls Summit

Who knows when the day will come that one of your products faces a recall?  It could be tomorrow … next week … a year from now.

Sadly, many firms are complacent about recalls — and woefully unprepared.  Yours may be among them.

Does your company have an up-to-date recall plan? Or is it an old one, in a dusty binder somewhere on a shelf — or buried deep in your SOP archives?

Do you know the last time your recall plan was reviewed?  Does it meet the FDA’s evolving standards for recalls?  Has it ever been tested with a mock audit?

If you answer “no” or “I don’t know” to any of these questions — or if you believe in the need to be proactive and prepared — you must plan NOW to attend the FDAnews conference Drug and Device Recalls Summit on April 29-30 in Bethesda, MD.

This is a must-attend event for those responsible for their organization’s recall readiness. In two action-packed days of expert presentations and enlightened discussions, you will learn:

  • The top 5 reasons internal recall committees fail – and how to fix them
  • How to put your internal recall committee through a “mock recall” to identify strengths and weaknesses — and tips on how to shore up your program
  • The most common and simple mistakes FDA finds in recall programs
  • The specific kinds of information you should supply the FDA to make your recall run more smoothly
  • How and why you must measure and document the financial and other costs of a recall
  • Tips to help you build procedures that will appropriately link your recall strategy to corrective and preventive action strategy
  • The different regulatory expectations in dozens of foreign markets
  • Understanding the implications of voluntary recalls versus mandatory recalls
  • How regulatory affairs can best function both internally and externally from the outset of a possible recall
  • Best practices for getting and keeping regulatory affairs and quality affairs on the same page during recalls
  • Proven strategies for introducing a product back to market
  • How to navigate complex legal issues and protect your firm against potential liability for mishandled recalls

After two days of “total immersion” in recall readiness, you'll return to your office with proven best practices and tools that will ensure your recall program will run smoothly. And, you'll be ready to confidently communicate about the program with the FDA and stakeholders. Register today.