FDA Inspectional Approach, Paul Bellamy (733 KB)
FDA Inspectional Approach, Paul Bellamy (733 KB)
FDA Inspectional Approach, Paul Bellamy (733 KB)
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TYPICAL PROBLEMS WITH<br />
INVESTIGATIONS<br />
• INVESTIGATION DOES NOT CONTAIN ALL<br />
PERTAINENT INFORMATION<br />
• THE CONCLUSION OF THE<br />
INVESTIGATION IS NOT SUPPORTED BY<br />
DATA OR DOCUMENTATION i.e. Was an<br />
experiment or test conducted to support<br />
the conclusion?<br />
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