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Modernization and Harmonization of Inspectional Approaches
Session Chair(s)
Stephen Mahoney, JD, MS
Head of Quality Policy and Advocacy
Gilead Sciences, United States
This session will discuss industry challenges, needs and feedback regarding international efforts currently underway to harmonize global inspection schemes.
Learning Objective : Discuss the latest efforts to harmonize global inspection schemes.
Speaker(s)
An Industry Perspective: Inspection Management - Fire Drill or Readiness?
Joanne Spallone
Novartis Pharmaceuticals Corporation, United States
Global Head, Franchise QA Operations and Strategy
Reforming FDA's Enforcement Process
Howard Sklamberg, JD, MA
Arnold & Porter, United States
Partner, Life Sciences and Healthcare Regulatory
International Inspections Issues and Successful Remediation
Thomas J. Cosgrove, JD
Covington & Burling LLP, United States
Partner