Annex 11 and 21 CFR Part 11: Comparisons for International Compliance

November 15, 2019
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Common Reasons for FDA 483 Inspectional Observations in Biologics Manufacturing Environments
Common Reasons for FDA 483 Inspectional Observations in Biologics Manufacturing Environments

Learn about the most common 483 observations and audit findings, and avoid warning letters by staying compl...

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21 CFR Part 11 Compliance Checklist
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If your company is planning to convert to an automated system for managing documents and processes, make s...