Using CDRH’s Medical Device Quality Data to Improve Your Bottom Line - Webinar CD/Transcript
Using CDRH’s Medical Device Quality Data to Improve Your Bottom Line
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, Cisco Vicenty and Daniel Walter do. And they’re about to show you.
Mr. Gaba — an attorney with Polsinelli LLP — Mr. Vicenty — the Program Manager for the Case for Quality within the Office of Compliance at FDA’s Center for Devices and Radiological Health — and Mr. Walter — Chief, Foreign Enforcement Branch, Division of International Compliance Operations, Office of Compliance, CDRH — 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!