FDA's Case for Quality: Non-Product Computer System Validation (Part 4 of 4)

In our final segment of the FDA: Case for Quality series, the conversation will be centered around FDA CDRH’s upcoming draft guidance, "Computer Software Assurance for Manufacturing, Operations, and Quality System Software". 

CDRH will also discuss identified issues, work that has been performed, and the emerging opportunities now available to companies in order to simplify their validation efforts, accelerate implementation, and leverage a risk-based approach to software assurance.

This free 60 minute webinar is presented by FDA Case for Quality Program Manager, Cisco Vicenty, who will present an overview on lessons learned from pilot program participants to conclude the final part of our program series. 

Watch the webinar

Specifically, this webinar will cover:
  • 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
Register Now  

Hosted by

Presenter: Francisco Vicenty

Case for Quality Program Manager, FDA

Jon Speer
Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru


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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