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04 12 22 -- Due Diligence When Acquiring A Biopharma Manufacturing Facility

04 20 21 -- FDA Inspections: Are Changes On The Horizon?

04.20.21 FDA Inspections: Are Changes On The Horizon?     To get the most out of data, you must ensure they are findable, accessible, interoperable, and reusable F.A.I.R. for short. Organizations simply don’t have the infrastructure in place to be able to capture data with context and then store them so that they can be searched and accessed with ease. We’ll explore how you can change that using the F.A.I.R. principles, which have been recognized as standards to enable for that potential to be realized. Featured Editorial By Kalah Auchincloss, Greenleaf Health, Inc. A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply. Kalah Auchincloss of Greenleaf Health provides a brief timeline of inspection-related events over the last year, discusses the impact, and examines the c

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