What is FDA Thinking? We Asked, They Answered!

An Interview with Francisco (Cisco) Vicenty – US FDA

By: Daniel R. Matlis, President

That is a question I often hear from industry executives around the globe.

To answer this question, I sat down with FDA’s Francisco Vicenty, for over an hour, to discuss a wide range of topics and gain an understanding of FDA’s current thinking on these topics. Cisco Vicenty is the Case for Quality Program Manager at FDA’s Office of Compliance, CDRH.


Driving a Culture of Quality in Industry

The overarching drive at FDA is enabling high levels of product excellence and innovation across industry and to provide patients with access to high quality, safe, and effective medical devices.  The agency wants to incentivize industry to adopt quality best practices; to adopt product quality excellence that drives improved patient outcomes.

The Value of Driving Product Quality

In fact, FDA leadership recognizes that it’s not about “Are you meeting the letter of the regulation anymore?” Now the discussion is about driving towards the idea that “we can do better and we can do more”.

To this end, the agency is shifting away from inspection and control and towards continuous improvement through organizational excellence based on data, and metrics.

The agency wants to enable and then focus on a continuous improvement mindset, both within the manufacturing space as well as in the regulatory space. In order to achieve this goal, the agency is establishing flexible regulatory paradigms that can be adjusted and accommodate specific situations and maturity of a given manufacturer.

Encouraging the Use of Technology & Automation

During our discussion we touched on a topic dear to my heart, the need to implement appropriate automation and data analytics technology to enable transformation. We also discussed how computer system validation is a significant barrier in the implementation of technology in Life-Sciences.

FDA also wants to see an increase in the use of automation data systems. The agency wants to encourage industry to implement solutions that support improved control and error-proofing and gain increased visibility into what’s happening with the process and the product as early as possible.

Validation is an Obstacle to Implementing Technology

The agency recognizes that CSV has been a barrier in the implementation of this type of technology and this investment in the automation that needs to happen.  This is primarily due to a lack of clarity on the agency’s part on CSV expectations for automation and technology systems.  The FDA recognizes CSV is a barrier to implementation and is working swiftly on addressing this.

Stay tuned as we share additional topics from this insightful conversation with FDA.

This webinar was hosted by Siemens PLM.




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