Medical Device Complaint SystemsStrategies for Managing Your Biggest Compliance Challenge

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It’s simply not good enough to say your complaint management system is compliant with CFR Part 820 — Quality System Regulation.  The FDA would also like it integrated with multiple other sections of the CFR and international regulations.

And, a proposed rule would require electronic submission of MDRs and compliance with 21 CFR Part 11, the FDA’s electronic records and signatures regulation.

Here’s the opportunity to find out — now — what you’ll be facing in the future.

Complaint management systems have long been an easy target for FDA inspectors.

Come up short in an inspection and the FDA can declare your entire system “out of control” ... and issue a Form 483 or a warning letter.

Now, to make matters worse, there’s a proposal on the table for electronic submission of MDRs.  Devicemakers will be required to comply with the FDA’s electronic records and signatures regulation, 21 CFR Part 11.

Companies that still rely on a paper system will have to install new software that must be validated. Estimates of the cost of full industry compliance are in the $58-$80 million range.

No wonder many device and diagnostics makers are up in arms.

But you don’t have to be among them. Get on the right side of this change — before it hits. Sign up for Medical Device Complaint Systems: Strategies for Managing Your Biggest Compliance Challenge.

This FDAnews-sponsored webinar features Dan O’Leary, a 30-year veteran of the quality wars, laying out what device and diagnostics makers like you need to know today. In 90 fast-paced minutes, Mr. O’Leary covers when (and how) to:

  • Determine the components of an integrated system
  • Conduct gap analysis
  • File either a 5-day or 30-day MDR report, as appropriate
  • Determine when a 10-day corrections or removals (C&R) report is needed
  • Learn about overlapping reporting requirements for MDRs and C&Rs
  • Map the process flow in an integrated complaint management system

You’ll also learn under which circumstances a seemingly simple report must be elevated to an MDR or a C&R.

You’ll discover 5 tips to continuously evaluate your systems for compliance ... which records you must keep to show you are obeying the rules ... how to take a holistic view to assure you’re complying with the many requirements.

And much more.

Medical Device Complaint Systems is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you work at the office or telecommute from your office at home.

Of course, Mr. O’Leary will be on hand to answer all of your questions. Simply submit them via email, and you’ll have answers by the time the session ends.

Key people throughout your company will benefit from taking part in this event. Best of all, everyone can do so at a cost that won’t break the budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.

Get comprehensive, guided training in complaint management. Learn which regulations apply and how to apply them. Gain the tools and techniques that put you on the FDA’s good side. Sign up now.

If you manufacture medical devices or diagnostics, this webinar is an ideal opportunity to acquire new skills or brush up old ones. It’s perfect for:

  • Quality assurance managers and staff
  • Regulatory affairs managers and staff
  • Complaint management staff
  • Risk management specialists
  • Design and development managers
  • Project managers
  • Process validation specialists
  • Auditors
  • Consultants/service providers
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • Risk management specialists
  • Sales/marketing personnel

Dan O’Leary has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He is President of Ombu Enterprises LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies.

He is an ASQ Certified biomedical auditor, quality auditor, quality engineer, reliability engineer and Six Sigma Black Belt, and is certified by APICS in resource management.

Register now!

Date: May 2–20, 2011
Location: Your office or conference room (no need to travel!)
Time: Anytime

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

Interested in registering multiple sites?

Significant tuition discounts are available for three or more sites from
the same company. You must register at the same time and
provide a single payment to take advantage of the discount. Register below
by clicking on add to cart and then change your quantity in the shopping cart.
The discount will be calculated automatically.

3-4 sites – 10%
7-9 sites – 20%
5-6 sites – 15%
10+ sites – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
with any questions.

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