戻る Agenda
Modernization and Harmonization of Inspectional Approaches
Session Chair(s)
Stephen Mahoney, JD, MS
Head of Quality Policy and Advocacy, Gilead, 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
Global Head, Franchise QA Operations and Strategy, Novartis Pharmaceuticals Corporation, United States
Reforming FDA's Enforcement Process
Howard Sklamberg, JD, MA
Partner, Life Sciences and Healthcare Regulatory, Arnold & Porter, United States
International Inspections Issues and Successful Remediation
Thomas J. Cosgrove, JD
Partner, Covington & Burling LLP, United States