Debunking Industry Myths on Regulatory Science FDA is moving Regulatory Science into the 21st century. To this end, the Agency is driving innovation of tools, …
FDA is Moving Regulatory Science into the 21st Century, Are You Ready? Read More »
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What to Expect in FDA’s Draft Guidance on Computer Software Assurance Read More »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 …
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 …
