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FDA Partners with Greenlight Guru: Case for Quality Webinar Series

Watch the Free Webinar Series

 

Top-quality medical devices help the FDA better protect and promote public health. And one of the top priorities for FDA's medical devices center is a focus on quality.

The FDA launched the Case for Quality in 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders. 

This program allows the FDA to recognize device manufacturers that are capable of consistently producing high-quality devices and continuously improving. 

Greenlight Guru is partnering with FDA CDRH to help spread the word and promote the Case for Quality initiative and its benefits to the medical device industry.

This four-part webinar series is presented by FDA Case for Quality Program Manager Cisco Vicenty and will present an overview on lessons learned from pilot program participants. 

 

SPECIFICALLY ThEsE WebinarS will Cover:

 

PART ONE: WHAT, WHY, AND HOW? CHANGING THE REGULATORY PARADIGM
  • Learn about CfQ – What it is, why we are doing it, and how we are engaging
  • Introduce pilot programs – Provide summary detail on various pilots at CDRH and associated with CfQ
  • Regulatory paradigm – How is FDA rethinking the regulatory engagement
PART TWO: VOLUNTARY PILOT PROGRAM AND STATUS UPDATE
  • Voluntary PMA Critical To Quality Pilot – Learn about the PMA CtQ pilot in detail
  • Voluntary Manufacturing and Product Quality Pilot – Provide detail on the voluntary program pilot and the current status, feedback, and observations
  • Introduce Issues and Concerns with Pilot or Activities
PART THREE: QUALITY VS COMPLIANCE METRICS AND WHAT'S NEXT
  • What you need to know about quality metrics and indicators versus compliance metrics and indicators
  • The reasoning behind FDA's shift towards quality
  • Real details of metrics that are now being shared by pilot participants and how the agency intends to use them
PART FOUR: NON-PRODUCT COMPUTER SYSTEM VALIDATION
  • A comprehensive look at CDRH’s work in the non-Product Computer System Validation space
  • Key issues identified during pilot program and the work that's been performed by CDRH
  • Learn about new opportunities for medical device companies to simplify efforts, accelerate implementations, and leverage a risk-based approach to software assurance

Who should attend?

  • Medical Device Industry Executives

  • Regulatory Affairs Professionals and Management

  • Quality Professionals and Management

  • Clinical Affairs Professionals and Management 

  • R&D Engineers and Management

 

 

Presenter

 Cisco Vicenty

Francisco Vicenty
Case for Quality Program Manager
FDA

Moderator

 

Jon Speer

Jon Speer
Founder & VP QA/RA
Greenlight Guru

greenlight-guru-logo

About greenlight guru

Greenlight Guru is a modern quality management software platform used by medical device companies in over 600 cities and 35 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS,

Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our home page to learn more.


 

 
ABOUT FDA CDRH

In keeping with our mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

We seek to continually improve our effectiveness in fulfilling our mission by planning strategically and regularly monitoring our progress.


 

 

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