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2021 - Structuring and Conducting Risk-Based Internal cGMP Compliance Audits
Date2021-03-02
Deadline2021-01-24
Venue, USA - United States 
KeywordsFDA cGMP guidelines; FDA cGMP compliance audits; FDA cGMP audit
Topics/Call fo Papers
Basic U.S. FDA's expectations – the CGMPs
The "target" -- Tougher FDA Expectations / Requirements
Avoid complacency from past "good" FDA / Notified Body / ISO audits
Key medical device and pharmaceutical CGMP concerns
A risk-based phased approach
FDA “model” CGMP inspections
Prove / maintain 'in control'
Fight “entropy”
The "target" -- Tougher FDA Expectations / Requirements
Avoid complacency from past "good" FDA / Notified Body / ISO audits
Key medical device and pharmaceutical CGMP concerns
A risk-based phased approach
FDA “model” CGMP inspections
Prove / maintain 'in control'
Fight “entropy”
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Last modified: 2020-12-07 17:14:23