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Modernization and Harmonization of Inspectional Approaches
Session Chair(s)
Stephen Mahoney, JD, MS
Executive Director, Global Compliance Policy and External Collaboration Americas
Genentech, A Member of the Roche Group, 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
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