Recap of the Institute of Packaging Professionals (IoPP) – Puerto Rico Chapter Meeting On August 22, 2019, I was invited by the IoPP – Puerto […]
What to Expect in FDA’s Draft Guidance on Computer Software Assurance Read More »
Q&A from an Axendia Straight from the Source (SftS) Webinar By: Francisco Vicenty, FDA, CDRH and Daniel R. Matlis, Axendia, President In our recent webinar, we
FDA Answers Your Questions on the New Approach to CSV Read More »
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 »
