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IVT Validation Week 2016 Meeting Review and Awards Presentations | IVT

REGULATORY PERSPECTIVES AND TECHNICAL CONTENT More than 45 presentations by 30 speakers were provided at this meeting.  These discussions include six presentations by current or former FDA and global regulatory agency personnel.  Regulatory presentations described the sequence of a simulated regulatory audit, FDA enforcement options, and current top regulatory challenges.  FDA focus on data and metrics was discussed.  Data integrity issues, a current key inspection issue, was discussed including actual inspection experience.  An approach to conduct effective risk assessments...

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