Falls Church, VA (PRWEB)
July 20, 2017
Using CDRH’s Medical Device Quality Data to Improve Your Bottom Line
**An FDAnews Webinar**
Aug. 9, 2017 — 1:30 p.m. – 3:00 p.m. ET
Device makers have been handed a secret weapon to passing inspections and boosting quality.
It’s known as the “CY2016 Annual FDA Medical Device Quality System Data” report. CDRH issues it quietly every year. It’s a goldmine of current data on inspections, Form 483 observations and warning letter citations that manufacturers can use to increase quality in manufacturing and compliance.
All they have to do now is figure out how.
Michael Gaba and Cisco Vicenty know how, and they’re going to show device makers.
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 take device makers on a deep dive into this all-important FDA document to 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!
The days of “gotcha” regulation are passing. The FDA wants to help device makers succeed, and the “CY2016 Annual FDA Medical Device Quality System Data” report is a great first step. Discover how to get the most out of it.
Meet the Presenters:
Michael Gaba, Shareholder, Polsinelli LLP, 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 is the Program Manager for the Case for Quality within the Office of Compliance at FDA’s Center for Devices and Radiological Health….