Siemens recently hosted a webinar featuring Cisco Vicenty who is a Program Manager with the FDA, and responsible for one of the FDA programs – A Case for Quality.
Why the Case for Quality program at the FDA? Because the risk to patients from quality issues was hampering innovation in manufacturing and product development practices. While the industry was focused on meeting regulatory requirements, they weren’t necessarily adopting best quality practices. They weren’t seeing the investment in automation and digital technologies that could actually move the needle on proactive quality. The Case for Quality was developed to engage stakeholders across the industry, including manufacturers, patients, and regulators, to understand what was driving organizational performance, and how behavior could shift from a focus on meeting compliance requirements to a focus on producing higher quality products.
Francisco shares information about where the FDA is today, how the FDA has responded in this pandemic, how to address the exchange of data and enable more flexibility between regulatory agencies and manufacturers, with the use of technology.
View the webinar today here !