FDAnews Announces Recall Management for Medical Devices Virtual Conference, May 1, 2014
Falls Church, VA (PRWEB) April 18, 2014 -- Recall Management for Medical Devices
**FDAnews Virtual Conference**
May 1, 2014 — 10:00 a.m. – 4:00 p.m. EDT
http://www.fdanews.com/RecallMgmntDeviceVC
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 do device manufacturers 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 a recall management program.
Who knows when the day will come that a product faces a recall? It could be tomorrow, next week or a year from now.
Sadly, many firms are complacent about recalls and woefully unprepared.
Is the company recall plan up-to-date? Or is it an old one, in a dusty binder somewhere on a shelf or buried deep in the SOP archives?
When was the last time the company recall plan was reviewed? Does it meet the FDA’s evolving standards for recalls? Has it ever been tested with a mock audit?
If the answer "no" or "Don't know" to any of these questions, or want to be proactive and prepared plan to attend the FDAnews virtual conference Recall Management for Medical Devices on May 1.
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, attendees 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 an internal recall committee through a “mock recall” to identify strengths and weaknesses — and tips on how to shore up the 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 the company
Recall Management for Medical Devices is a must-attend event for colleagues from the manufacturing floor to materials management, and the legal counsel’s office to the executive suite. The following will benefit:
• Quality assurance/quality control
• Operations
• Manufacturing
• Materials management
• Purchasing
• Packaging and labeling
• Plant engineering
• In-bound testing and certification
• Regulatory affairs
• Legal counsel
Attendee Resource Toolkit — Registered attendees will also receive the following resources to help them better manage their supplier control program:
• Slide decks from all five presentations
• FDA’s 21 CFR 820.50 regulation
• A compilation of recent FDAnews articles related to supplier control problems at medical device manufacturers
• GHTF/SG3/N17:2008 Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained From Suppliers
Meet the 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)
Conference Details
Recall Management for Medical Devices
**FDAnews Virtual Conference**
May 1, 2014 — 10:00 a.m. – 4:00 p.m. EDT
http://www.fdanews.com/RecallMgmntDeviceVC
Tuition
$1,297 per site -- includes virtual conference registration and audio cds and transcripts
Easy Ways to Register
Online: http://www.fdanews.com/RecallMgmntDeviceVC
By phone: 888-838-5578 or 703-538-7600
About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
Michelle Butler, FDANEWS, http://www.fdanews.com, +1 (703) 538-7665, [email protected]
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