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

Watch the Free Webinar (& get all the Case for Quality recordings)


In our final segment of the FDA: Case for Quality series, the conversation will be centered around FDA CDRH’s upcoming draft guidance, "Computer Software Assurance for Manufacturing, Operations, and Quality System Software".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


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 Industry Executives

  • Regulatory Affairs Professionals and Management

  • Quality Professionals and Management

  • Clinical Affairs Professionals and Management 

  • R&D Engineers and Management




 Cisco Vicenty

Francisco Vicenty
Case for Quality Program Manager



Jon Speer

Jon Speer
Founder & VP QA/RA
Greenlight Guru


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.



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.