10 years ago, Congress provided FDA the statutory authority to conduct risk-based inspection, with the promulgation of the FDA Safety and Innovation Act (FDASIA). The […]
Quality Metrics Support Improved Quality Across the Value Network Read More »
By: Jared N. Matlis, Research Assistant Preparedness is a skill which is necessary for success in any situation, whether it is a job, schooling, or
3D Printing Capacity Critical in Preparing for a Pandemic Read More »
Automating Electronic Batch Record review is a key benefit of Modernizing Manufacturing Operations. Yet concerns regarding FDA’s acceptance of Review by Exception (RBE) has prevented
FDA Debunks Industry Myths on Electronic Batch Records and Review by Exceptions Read More »
The FDA has recognized that current perceptions and approaches to computer system validation (CSV) are a significant barrier to Digital Transformation and Manufacturing Modernization. The
FDA Shares Insights on Digital Transformation & Manufacturing Modernization Read More »
A Straight from the Source Webinar The interest in 3D Printing (a/k/a Additive Manufacturing) has risen spectacularly the last decade. The use of 3D Printing
FDA Discusses Challenges and Opportunities for 3D Printing in Life Sciences Read More »
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What to Expect in FDA’s Draft Guidance on Computer Software Assurance Read More »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 »
