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December 1 & 2, 2008 - Malvern, PA
This course discusses the FDA’s regulatory authority for approving medical devices prior to marketing, and the compliance programs used in enforcing its authorities. It also provides FDA strategies regarding inspections of manufacturing sites, and compliance actions that may result from these. The various regulatory processes are presented, including major enforcement tools such as warning letters, injunctions and civil money penalties. The course provides the attendees with the most important regulatory resource materials needed to understand agency behavior.
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This course discusses the FDA’s regulatory authority for approving medical devices prior to marketing, and the compliance programs used in enforcing its authorities. It also provides FDA strategies regarding inspections of manufacturing sites, and compliance actions that may result from these. The various regulatory processes are presented, including major enforcement tools such as warning letters, injunctions and civil money penalties. The course provides the attendees with the most important regulatory resource materials needed to understand agency behavior.
Discuss Add this link to... Bury
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