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ExL’s 8th Trial Master File Summit

January 22-24, 2019  |  Hilton Orlando Lake Buena Vista  |  Orlando, FL

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15% off standard pricing rates using Discount Code AVOCAVIP


Join Avoca for the following session:

Thursday, January 24 – 9:10am  |  Main Conference Day Two

[Panel] Prepare for a TMF Inspection With a Quality Management System

  • Manifest prioritization drivers in your metrics to avoid critical findings
  • Hear examples of mock audits improving inspection readiness by informing process modifications
  • Hear how various constituencies are involved in inspections
  • Conduct audits in accordance with inspection trends and pending changes
  • Survey common pitfalls for inspections and discuss how they may be avoided


Janis Hall, MBA, Senior Consultant, The Avoca Group


Moderator:  Bryan Souder, Director, TMF Head, Merck


  • Sheryl Crean, Director Quality Assurance Strategic Advice- Science Unit QA, GCP and PV, AstraZeneca
  • Janis Hall, Senior Consultant, The Avoca Group
  • Dawn M. Niccum, Senior Director of QA and Compliance, Inseption Group
  • Melissa Umbehauer Chiasson, Senior Manager, Process, Training and Compliance, Takeda
  • Stephanie Viscomi, Associate Director, Clinical Trial Office, Immunogen


To schedule a meeting with an Avoca representative at this event, contact us.


Webinar: TMF Inspection Readiness (IR): Avoiding IRregularities IRrespective of International Regulatory Agency Access the Recording and Slides >>