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2019 - The Most Serious FDA 483s - How to Avoid Them
Date2019-03-12
Deadline2019-03-12
VenuePalo Alto, USA - United States 
KeywordsAvoiding serious FDA 483s; Avoiding FDA Form 483 observat; FDA CGMP compliance audits
Topics/Call fo Papers
Recent Most Serious FDA 483s
The "Whys"
Root Causes
Avoid complacency from past "good" FDA audits.
Shifting focus
Maximize scarce resources
The "risk-based" phased approach
Maintain "the edge" -- fight "entropy"
The "Whys"
Root Causes
Avoid complacency from past "good" FDA audits.
Shifting focus
Maximize scarce resources
The "risk-based" phased approach
Maintain "the edge" -- fight "entropy"
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Last modified: 2019-01-31 23:50:41