FDA and Industry Find Common Ground Driving a Culture of Quality
DATE: March 1, 2017
TIME: 1:30PM Eastern
Industry leaders and regulators are working on the Case for Quality (CfQ) initiative to shift their focus from compliance to quality by giving greater focus and emphasis to critical-to-quality practices throughout the lifecycle of the product.
Would you like to reduce your regulatory burden? Pay dividends in enhanced and predictable product performance? Streamline processes resulting in operational efficiencies? Reduce waste driving to lower costs and improved profitability?
Join Sean Boyd — Deputy Director for Regulatory Affairs, CDRH’s Office of Compliance — Francisco (Cisco) Vicenty — Program Manager (Acting), Case for Quality, FDA — and Daniel R. Matlis — President, Axendia — on March 1st when they’ll discuss the effect the CfQ will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient.
You Will Learn:
- How to stop routine FDA inspections and forego pre-approval inspections
- How the Case for Quality is creating a competitive marketplace for device quality
- What are the market and regulatory incentives for device manufacturers
- How to manage results using quality tools
- What are the quality outcome metrics FDA will collect and monitor
- Why you need to manage medical devices across their total lifecycle
- How to drive accelerated innovation volume and velocity
- How to use an integrated approach to manage increasing device complexities
- How to sharpen your focus on developing high quality medical devices aimed at improving patient outcomes
- How to support end to end traceability and intelligence across the entire product lifecycle