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Handling OOS Test Results and Failure Investigations
No or inadequate procedures for handling out of specification (OOS) situations, failure investigations and corrective and preventive actions (CAPA) are amongst the most frequently found deviations in FDA warning letters.
Recorded
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$295.00
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FDA's New Enforcement of 21 CFR Part 11
FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations.
Recorded
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Duration:75 Minutes
$295.00
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