Modern approaches to manufacturing and inspections for modern times

4:00 PM - 4:45 PM (EDT), Thursday, June 17, 2021
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The COVID-19 pandemic and scientific and technological advancements have made modern approaches to manufacturing and inspections more feasible. This session will feature discussion by FDA and Industry regarding advanced manufacturing technologies and the utilization of virtual tools for inspectional activities. Updates regarding experiences with the FDA CDER Emerging Technology Team (ETT) and CBER Advanced Technology Team (CATT) will be shared. Discussion will also include real world learnings during COVID on modern and flexible approaches taken to ensure treatments and cures are still able to be manufactured and inspected as well as how these modernizations and flexibilities may become more common practice.