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FDA's Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation | King & Spalding

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document...
International Society For Pharmaceutical Engineering Drug Administration Staff Computer Software Assurance For Production Quality System Software Principles Of Software Validation Association For The Advancement Of Medical Instrumentation

ISPE Announces the 2022–2023 ISPE International Board of Directors Election Results

ISPE Announces the 2022–2023 ISPE International Board of Directors Election Results(NORTH BETHESDA, MARYLAND, USA, 31 AUGUST 2022) — The International Society of Pharmaceutical Engineering (ISPE) is pleased to announce the results of its 2022–2023 International Board of Directors election. The...
United States North Bethesda Norman Goldschmidt Michael Rutherford Teresa Minero Georg Singewald

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