FDA's Case for Quality Webinar Series

FREE ON-DEMAND WEBINAR

FDA Partners with Greenlight Guru: Case for Quality Webinar Series

FDA is able to protect and promote public health by enabling the production and commercialization of life-saving medical devices in the U.S. market. 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.

Watch the webinar

Specifically, this webinar 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 Executives
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management

Hosted by

Presenter: Francisco Vicenty

Case for Quality Program Manager, FDA

Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru

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..

About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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