Common Reasons for FDA 483 Inspectional Observations in Biologics Manufacturing Environments

November 15, 2019
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FDA Fronts Pivotal Life Sciences Trend in 2020
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This publication provides an in-depth look at the FDA’s transformation and addresses how the agency’s initi...

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Annex 11 and 21 CFR Part 11: Comparisons for International Compliance
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The two essential resources regarding the validation of computer systems are: the FDA’s 21 CFR Part 11 and ...