Using CDRH’s Medical Device Quality Data to Improve Your Bottom Line

Wednesday, Aug. 9, 2017 · 1:30 p.m. - 3:00 p.m. EDT

The “CY2016 Annual FDA Medical Device Quality System Data” report is an information goldmine for devicemakers — a key to better inspection outcomes as well as greater quality in manufacturing.

In its pages you’ll discover hot-off-the-press aggregate data on inspections, Form 483 observations and warning letter citations that you can use to increase quality in manufacturing and compliance.

Sadly, not enough devicemakers know how to get the most out of this valuable annual report from the CDRH.

But Michael Gaba and Cisco Vicenty do. And they’re about to show you.

Mr. Gaba — an attorney with Polsinelli LLP specializes in sifting useful information out of masses of raw data — and Mr. Vicenty —  the Program Manager for the Case for Quality within the Office of Compliance at FDA’s Center for Devices and Radiological Health — will help you get better inspection outcomes, boost manufacturing quality, and avoid FDA sanctions.

Participants will discover:

  • Missteps that trigger warning letters and 483s

  • How to use CDRH compliance data to improve inspection outcomes

  • How to boost manufacturing quality using CDRH compliance data

  • How to sift the raw numbers for gold — key data and statistical trends

  • Compliance strategies to avoid post-inspection escalation

  • And much more!

Why spend literally thousands of dollars per hour bringing Mr. Gaba to your organization for a sit-down when it’s so easy — and inexpensive — to get the most out of this free document from the CDRH? Register now.

Webinar plus Audio CD/Transcript
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$487

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Webinar only
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$287

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24/7 Encore plus Audio CD/Transcript
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$487

add to cart

24/7 Encore Presentation
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$287

add to cart

Audio CD/Transcript
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$287

add to cart

 

Who Will Benefit

  • Regulatory affairs/compliance
  • QA/QR/QC managers
  • Manufacturing executives
  • Planning/corporate strategy
  • Legal counsel
  • Consultants

 

Meet Your Presenters

Michael Gaba

Shareholder
Polsinelli LLP

Michael Gaba provides strategic regulatory, reimbursement and public policy counsel to device and biotech manufacturers. Working as an extension of each company’s legal and business teams, he draws on 20+ years of resolving Medicare coverage, coding, and reimbursement disputes with the Centers for Medicare and Medicaid Services (CMS) and the FDA to maximize compensation.

Francisco (Cisco) Vicenty

Program Manager for the Case for Quality within the Office of Compliance
FDA’s Center for Devices and Radiological Health

Francisco (Cisco) Vicenty is the Program Manager for the Case for Quality within the Office of Compliance at FDA’s Center for Devices and Radiological Health. This effort is part of the CDRH strategic priorities for 2016 and 2017. This strategic priority will improve access and outcomes for patients by engaging industry, payers, providers, and patients in order to increase focus on the quality and performance of medical devices.

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