By: Thomas O’Connor, Division of Product Quality Research Director, US FDA FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of […]
FDA is Enabling Innovation and Modernization Read More »
A Straight from the Source Webinar Available On-Demand FDA is committed to supporting and enabling pharmaceutical innovation and modernization. The Agency recognizes that continuous manufacturing
FDA Shares Quality Considerations for Continuous Manufacturing Read More »
Computer System Assurance in Support of Manufacturing 4.0 By: Daniel R. Matlis, President Computer System Validation (CSA) is a streamlined approach to validation that supports
eBook: CSA – A Streamlined Approach to Validation Read More »
A Straight from the Source Webinar The FDA has recognized that existing perceptions and approaches to computer system validation (CSV) are a significant barrier to
FDA Shares a New Approach to CSV Read More »
Stop Validating Computer Systems to Death! By: Daniel R. Matlis, President “FDA emphasizes that manufacturers are responsible for the adequacy of the software used in
At 21, Computer System Validation Comes of Age Read More »
by Axendia Staff FDA’s Executive Forum on the “Case for Quality Initiative” brought together Industry Executives, FDA Officials and Industry Advisors in a series of
New Report: FDA’s Executive Forum on the “Case for Quality Initiative” Read More »
