Center for Professional Innovation & Education, Inc., Berlin, Germany
May 30 & 31, 2013
This course discusses the FDA’s regulatory authority for approving medical devices prior to marketing and the compliance programs used in enforcing its authorities during the manufacture and post-marketing reporting systems. It also provides FDA strategies towards inspections of manufacturing sites, and compliance actions that may result from these inspections. The course provides the attendees with the most important regulatory resource materials needed to understand agency policies and enforcement actions. Issues to be covered include: Structure of the FDA and current FDA regulatory compliance practices - how to work with FDA investigators
The regulatory approval process – “what the FDA is looking for” in 510ks, PMAs and other pre-approval applications
The scope of FDA’s compliance programs, policies and potential enforcement actions
Discussion of post-marketing notification and reporting programs
Strategies for development of an in-house compliance program for GMPs which ensure successful inspectional outcomes
Recent FDA enforcement statistics
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