Ten Most Common Reasons for FDA 483 Inspectional Observations in Pharmaceutical Environments

November 15, 2019
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eTMF Management Essentials
eTMF Management Essentials

Every organization engaged in a clinical trial must manage and maintain all trial-related content, document...

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ICH Q10 - Pharmaceutical Quality Systems - 'An Opportunity for Us All'
ICH Q10 - Pharmaceutical Quality Systems - 'An Opportunity for Us All'

The ICH Q10 Guideline 'pharmaceutical quality systems' was signed off as a Step 4 document at the ICH meeti...