Medical Device "Silent Recalls" CDRH Is On the Lookout - Are You Prepared?

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Under 21 CFR Part 806, it’s up to you to determine whether a device malfunction must be reported to the FDA. To do so, you must weigh adverse events and estimate the likelihood of more events occurring — and the probability of injuries.

If there’s a problem with a device, where do you draw the line between a routine servicing issue and a “risk to health” you must report to CDRH?

With the FDA cracking down on so-called silent recalls, making the wrong decision can lead straight to 483s, warning letters and even product seizures. 

Nearly every devicemaker eventually encounters a serious product problem — and FDA inspectors are on the lookout for “silent recalls” as never before.

CDRH Director Jeffrey Shuren is responding to devicemakers’ concerns that a “corrective fix” pilot program forces them to recall older models when new versions are introduced — even when there are no consumer complaints submitted on the older device. Shuren hopes that information from a new regulatory science meeting in February 2010, along with findings from an internal task force formed to evaluate CDRH’s science practices, will lead to a recall practice policy.

Attend this 90-minute webinar with quality and compliance expert Michael Patrick Barile and you can stay proactive, making good decisions as device problems arise and preparing effectively for inspections. 

Sign up your entire team for clear guidance on every aspect of 21 CFR Part 806 compliance, including:

  • What events must be reported, who is the responsible party and what deadlines apply
  • A step-by-step walkthrough of the FDA’s Health Hazard Evaluation form used to classify a recall
  • Recordkeeping requirements that apply even if an event isn’t reportable
  • 13 items that must be included with your removal or correction report
  • 4 crucial steps to take before the inspection, including how to produce a single file containing all the information the inspector will want
  • 6 keys to managing an inspection
  • Dos and don’ts for clearing inspection hurdles (such as eliminating any “off- the-record” conversations)
  • Real-world case study of how a company’s failure to properly report a device field correction resulted in a warning letter
  • Where to send reports in the U.S., EU, Canada and Japan

Past attendees of this popular webinar weigh in favorably:

“This course provided a clearer view of how and when to communicate with FDA, giving me more confidence in how to handle the reporting process.”
Richard Westrich, Vice-President, Regulatory Affairs and Quality Assurance, Ziehm Imaging, Inc.

“I thought this was easy to follow and it was a clear presentation.”
Christy Oviatt, Senior Regulatory Affairs Specialist, KCI USA, Inc.

Of course, Mr. Barile will be on hand to field your questions, too. Simply submit your questions via email, and you’ll have answers by the time the session ends.

And like every FDAnews webinar, Medical Device “Silent Recalls” is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your office-in-home.

Better yet, one low registration fee per facility means you can sign up 10 — 20 — or more — of your colleagues and never pay a penny more. (Who should you sign up? See “Who Will Benefit,” below, for recommendations.)

The FDA is fed up with “silent recalls.” The agency considers every inspection to be an opportunity to search for evidence that they’ve occurred.

Protect your company and be prepared by attending Mr. Barile’s repeat performance of Medical Device “Silent Recalls” on Thursday, April 15.

  • Compliance officers
  • Medical affairs
  • Manufacturing
  • Operations
  • General/corporate counsel
  • Regulatory/legislative affairs professionals
  • Plant engineering
  • QA/QC

Michael Patrick Barile, founder and managing partner of Barile and Associates, has more than 26 years of experience in the medical device, pharmaceutical, human tissue and biotechnology industries. He has held the senior quality assurance position in both start-up and large multinational corporations, specializing in difficult turnaround situations. Mr. Barile’s depth of experience in both line and corporate management has given him a unique and practical hands-on expertise with a wide variety of challenges over a diverse range of product technologies. A recognized expert in risk management, software and process validation, continuous improvement methods and quality systems, Mr. Barile lectures worldwide in seminars and for various trade groups.

Register now!

Date: Thursday, April 15, 2010
Location: Your office or conference room (no need to travel!)
Time: 1:30 p.m. – 3:00 p.m. EDT
  12:30 p.m. – 2:00 p.m. CDT
  11:30 a.m. – 1:00 p.m. MDT
  10:30 a.m. – 12:00 p.m. PDT
  6:30 p.m. – 8:00 p.m. GDT

Gather your team for maximum benefit! Your investment is for one dial-in.

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