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Conference Directory
Conduct of the Tougher U.S. FDA cGMP Inspection
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Venue Name: Online Webinar
Country: United States of America
City: Palo Alto
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
Keywords: Senior management,Regulatory Affairs,Quality Assurance,Production,Engineering,All personnel involved in a U S FDA-regulated environment
Start Date of Conference:: 12-08-2009
End Date of Conference: 12-08-2009
Description of Conference: This cGMP Inspection training Webinar will discuss how the on-site CGMP(Current Good Manufacturing Practices) compliance audit is changing and how a new tougher CGMP audit is being conducted by investigators based on new regulatory climate.
Areas Covered in the seminar:
* The changing regulatory climate.
* Avoid complacency from past "good" FDA audits .
* Initial contacts and management team meeting.
* The tour and systems audit.
* Drilling down.
* Documentation / records issues.
* Damage control.
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2009 
