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. 

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