Complaint Handling and Medical Device Reporting
Offered for One Day Only, Sept. 25, 2014 • At Your Convenience
Your Expert Presenter
Mike Heyl, an attorney with Hogan Lovell, specializes in post-market compliance and enforcement in the medical device sector, including the FDA’s Quality System Regulation (QSR), adverse event reporting and field action requirements. In addition, he helps conduct internal investigation where companies are accused of alleged regulatory violations; reviews and drafts standard operating procedures; assists with import and export issues; conducts regulatory due diligence; negotiates corporate mergers and acquisitions and initial public offerings; creates and implements corrective action plans, and provides wide-ranging advice on device-related regulatory issues.
When devices displease customers, they complain. How you respond is another matter. Tired of FDA sanctions for complaint-handling glitches?
Mark your calendar for Thursday, Sept. 25, for On-Demand access to Michael Heyl’s immensely popular webinar on complaint handling.
Here’s what our satisfied registrants had to say on what they liked about this webinar:
When it comes to getting in trouble with the FDA, devicemakers’ customers are their biggest headache.
Year in and year out, at least 65% of warning letters include citations for complaint handling. For the last few years complaint management was near the top of FDA’s most commonly cited list. In some years more than 100 Warning Letters citing CFR 820.198 violations were issued.
A deeper analysis shows exactly what FDA is looking for — and often finds:
And the challenges are heating up. You can take the mystery out of complaint handling and MDR. Sign up today for FDAnews’ on-demand webinar, Complaint Handling and Medical Device Reporting: Where Inspectors Look First.
Your presenter, noted legal expert Michael Heyl, has developed a compliance roadmap that saves time, money and headaches for device manufacturing companies like yours.
In 90 fast-paced minutes, you’ll gain a clear understand of what FDA investigators look for when evaluating complaint handling and medical device reporting programs. A short quiz helps you understand where you need help … and where you’re doing things right.
You’ll discover what the FDA inspectors look for when they enter your shop, plus:
Customer complaints will never go away. It’s worth 90 minutes to discover the right way to handle them.
Please note; this webinar has been previously recorded and no questions will be taken during the presentation. You may listen to the recording at your convenience on Sept. 25.
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