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

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document...

A Practical Guide To Navigate The EUs Revised GMP Annex 1 - Vimarsana News

A Practical Guide To Navigate The EUs Revised GMP Annex 1

The EU's final version of the GMP Annex 1 is now published, and it's time to take action. This article shares a road map to navigate what is...

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

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...

Replacing The MACMACO With The MSC Rethinking How Cleaning Validation Limits Are Calculated - Vimarsana News

Replacing The MACMACO With The MSC Rethinking How Cleaning Validation Limits Are Calculated

Two of the most commonly used terms used in pharmaceutical cleaning validation are the Maximum Allowable Carryover (MAC or MACO) and the Maximum Safe...

ISPE Announces 2022-2023 International Board of Directors Election Results - Vimarsana News

ISPE Announces 2022-2023 International Board of Directors Election Results

North Bethesda, MD (PRWEB) August 31, 2022 -- The International Society of Pharmaceutical Engineering (ISPE) is pleased to announce the results of its

Source: prweb.com