05.17.21 -- Are You Ready For The FDA's "Data Effect" Tsunami? 8 Steps To Prepare
State-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products. Several vendors offer development-scale to commercial-scale continuous downstream chromatography systems. When adopting continuous technology, it is critical to demonstrate that continuous downstream processes are comparable to batch-mode downstream processes and provide the supporting comparability data for technical and business decisions. Access the case study to learn more. Featured Editorial By Matt Collins, Cignyl, and John Giantsidis, CyberActa, Inc. The FDA is moving forward with its Data Modernization Action Plan (DMAP), the next leg of the Technology Modernization Action Plan. Why is this a tsunami? Because you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more! Here's what you can do to position yourself for success.