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Thursday September 26, 2024 4:00pm - 4:45pm EDT
Navigate the New Normal of Inspection Readiness and Create a Roadmap for Compliance  
    • Review how GCP inspections have changed post-COVID 
    • Share best practices for working with partners to ensure inspection readiness  
    • Understand the practical insights and tools to conduct thorough clinical quality due diligence during and after M&A transactions 
    • Evaluate needed resources and strategies for best leveraging them to ensure your study is inspection- prepared  
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 Matthew Burtt

Matthew Burtt

Senior Director, Internal Audits & Inspections, AbbVie
Matt leads a diverse, cross-disciplinary team of Quality Professionals, delivering strong internal Quality Oversight via risk-based audit programs, and developing key insights that enable real-time inspection preparation by Inspection Management team members also under his stewardship... Read More →
avatar for Priya Chaturvedi, Ph.D.

Priya Chaturvedi, Ph.D.

Vice President, Head of Global Clinical Quality, Eisai
Priya Chaturvedi is Vice President, Head of Global Clinical Quality at Eisai Inc. She has responsibility for Global Clinical Quality Assurance, Clinical Quality Management and Global Process and Standards. She joined Eisai in 2019. Prior to that, she was Executive Director, CQA at... Read More →
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 4:00pm - 4:45pm EDT
  Clinical Quality Track
  • Qtag clinicalqualityfeaturedsession

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