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Wednesday, June 27 • 2:00pm - 3:15pm
#374: Modernization and Harmonization of Inspectional Approaches

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Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-671-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss industry challenges, needs and feedback regarding international efforts currently underway to harmonize global inspection schemes.

Learning Objectives

Discuss the latest efforts to harmonize global inspection schemes.


Stephen Mahoney


An Industry Perspective: Inspection Management - Fire Drill or Readiness?
Joanne Spallone

Reforming FDA's Enforcement Process
Howard Sklamberg, JD, MA

International Inspections Issues and Successful Remediation
Thomas J. Cosgrove, JD

avatar for Thomas Cosgrove

Thomas Cosgrove

Partner, Covington & Burling LLP
Tom Cosgrove is a partner in Covington’s Food, Drug and Device Practice Group. He joined Covington in 2017 from the Food and Drug Administration (FDA), where he was a senior official charged with ensuring the quality of drugs and therapeutic biologics marketed to U.S. patients... Read More →
avatar for Stephen Mahoney

Stephen Mahoney

Executive Director, Global Compliance Policy and External Collaboration Americas, Genentech, A Member of the Roche Group, United States
Stephen Mahoney is an Executive Director in Global Quality and Compliance at Genentech, Inc. In this role, he advises senior leaders on critical regulatory and manufacturing matters. Previously, Stephen served as a Compliance Officer in the FDA's Center for Drug Evaluation and Research... Read More →
avatar for Howard Sklamberg

Howard Sklamberg

Partner, Health Group, Akin Gump Strauss Hauer & Feld LLP
Howard Sklamberg is a partner in Akin Gump’s health care and life sciences practice. From 2014 to April 2017, he was FDA’s Deputy Commissioner for Global Regulatory Operations & Policy, where he oversaw FDA quality and safety efforts, including development of standards, field... Read More →

Joanne Spallone

Global Head, Franchise QA Operations and Strategy, Novartis Pharmaceuticals Corporation
Joanne has spent over 37 years in the pharmaceutical industry and approximately 25 years in clinical/pharmactovigilance quality assurance functions. She has managed QA/Audit functions with responsibility for both GCP and Pharmacovigilance activities. Currently, she heads Global Development... Read More →

Wednesday June 27, 2018 2:00pm - 3:15pm EDT
Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Session