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2020 - Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

Date2020-06-30

Deadline2020-06-20

VenueOnline event, USA - United States USA - United States

KeywordsFDA cGMP guidelines; FDA cGMP compliance audits; FDA cGMP audit

Websitehttps://www.complianceonline.com/us-fda-...

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”

Last modified: 2020-05-16 23:38:40