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Panel: Navigating the New Normal of Inspection Readiness
Thursday September 26, 2024 5:00pm - 5:45pm EDT
  • Review what has changed in how inspections are managed post-COVID including remote/hybrid models and changes within inspectorates
  • Share vendor partner best practices and how they can best support sponsor organizations during an inspection
  • Understand the practical insights and tools to conduct thorough clinical quality due diligence and enhancing preparedness for regulatory inspections during and after mergers and acquisitions
  • Discuss the challenges with validating electronic health records based on EMA’s increased focus on electronic systems during inspections and the implications of this for the industry
Moderators
avatar for Priya Annamalai

Priya Annamalai

Director, Inspection Program – Quality Operations, Quality Assurance, Astellas
My professional career spans across various QA and compliance roles within the pharmaceutical industry with responsibilities in the areas of Quality Systems/CAPA management, regulatory intelligence, product complaints, pharmacovigilance and most recently, leading global regulatory... Read More →
Speakers
avatar for Mary MacDonald, MS, RQAP-GCP

Mary MacDonald, MS, RQAP-GCP

Head of Clinical Quality Assurance, Neuroscience, Takeda
Mary MacDonald is the Head of Clinical Quality Assurance, Neuroscience. In this role she partners with the Neuroscience Therapeutic Area Unit and additional quality and research and development business partners to ensure compliance and inspection readiness for all Takeda clinical... Read More →
Thursday September 26, 2024 5:00pm - 5:45pm EDT
  Clinical Quality Track

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