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The late Neville Meaney’s warning not to let cultural loyalties cloud the pursuit of national interest remains of vital importance to determining Australia’s role in the world.
01.14.21 -- Introduction To ASTM E3263-20 On Qualification Of Visual Inspection For Residues This report helps biopharmaceutical companies make more informed CMO decisions and helps CMOs optimize operational and marketing strategies. ISR presents data on 509 service encounters from 179 respondents who have been involved in outsourced biologics API projects in the past 18 months. Learn more here. Featured Editorial By Andrew Walsh, Ralph Basile, Ovais Mohammad, Stéphane Cousin, Mariann Neverovitch, and Osamu Shirokizawa The new E3263 standard provides ...
The Evolving Role Of The GxP Archivist By Stuart Ward, Bob McDowall, Damien Tiller This need to protect the data encompasses intellectual property and/or regulatory data integral for marketing submissions. Therefore, ensuring the archivist can guarantee adequate protection and control for regulatory data is critical for organizations to meet their business goals. According to the AGIT Guidelines for the Archiving of Electronic Raw Data in a GLP Environment published in 2018, “the archivist is responsible for all aspects of electronic archiving and should have full control of all activ...