Tenth Annual FDA Inspections Summit

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2015 Summit Highlights

4 panels featuring current and former FDA officials, including:

  • Understanding FDA’s Quality Metrics Initiative — what’s the latest on the quality initiative and how can you get prepared for what’s coming?
  • A day in the life of an investigator — how inspectors prepare and approach assigned inspections
  • Discussing inspectional protocols — how should you treat investigators when they are in your facility
  • Understanding proper training methods to reduce 483s

What to expect with FDA’s Mutual Inspection Program With Europe

Understanding OPQ’s New Inspection and Reporting Plan, Organizational Structure and New Director

FDA’s Office of Regulatory Affairs: Enforcement Update

INVITED FDA Speakers:

JANET WOODCOCK
Director
CDER, FDA

MELINDA PLAISIER
Associate Commissioner
ORA, FDA

PHIL PONTIKOS
CSO, National Device
Expert, OMPTO, ORA,
FDA, Columbus, OH

 

 

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