Recall Management for Medical Devices

Recall Management for Medical Devices - Webinar CD/Transcript

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Device recalls increased 28% last year, what some industry observers have called a “recall-o-rama.”

Thoratec, Respironics, Teleflex and Tandem Diabetes Care are just a few of the companies that have been hit.

How can you avoid being next?

Some device 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 devicemakers.

But there are ways to significantly improve your recall management program.

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 order the FDAnews virtual conference Recall Management for Medical Devices CD and transcript.

This is a must-attend virtual conference for those responsible for their organization's recall readiness. In six action-packed hours of expert presentations and enlightened discussions, you will learn:

  • The top 5 reasons internal recall committees fail — and how to fix them
  • The tools and tactics to quickly and accurately determine the true scope of the recall, including affected products and consignee lists in the US and outside the US
  • 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
  • What lessons do prior recalls teach about financial risk management and cost-capture planning, before a recall happens?
  • Recall Process Lifecycle — SOPs, Preparation and Effective Execution
  • How to update authorities/governing bodies in a proactive way to best protect patients and your company

Complete Conference Agenda

Recall Management for Medical Devices is a must for colleagues from the manufacturing floor to materials management, and the legal counsel’s office to the executive suite. Make sure to order if you work in:

  • Quality assurance/quality control
  • Operations
  • Manufacturing
  • Materials management
  • Purchasing
  • Packaging and labeling
  • Plant engineering
  • In-bound testing and certification
  • Regulatory affairs
  • Legal counsel

Whether you're a device manufacturer, diagnostics manufacturer, contract manufacturing organization, or a raw materials and sub-assembly manufacturer, this virtual conference CD and transcript will be a godsend. You don't have to face the difficulties with outsourcing alone.

Meet Your Faculty

  • Joe Falvo, Senior Manager: Post Market Risk Management, Ortho Clinical Diagnostics
  • Todd Halpern, Assistant General Counsel, Regulatory Law, Pfizer
  • Marialuisa (“ML”) Gallozzi, Partner, Covington & Burling
  • Suzan Charlton, Special Counsel, Covington & Burling
  • Mary Swift, Senior Manager, Regulatory Affairs, Terumo Cardiovascular Systems (invited)