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Session 3 Track 3: How Audit and Inspection Ready is Your Organization?
Session Chair(s)
Laura J. Sherman, MBA
Training Partner, Clinical Business Operations
Vertex Pharmaceuticals, Inc., United States
Learning Objective : Understand how thorough mapping of TMF documentation and review of the systems and technical solutions can improve audit and inspection readiness and how this mapping could be carried out. Understand how to interpret the requirements for a readily available and directly accessible electronic trial master file (eTMF) and how this will impact your organisation.
Speaker(s)
TMF Case Study for Being Inspection Ready
Dorte Frejwald Christiansen, MA
NNIT, Denmark
Principal Consultant
Creating Business Impact From Your Compliance Training
Sheri Winter
Caveo Learning, United States
Director, Client Development
Inspection Readiness from a GCP QA Auditor’s Perspective
Rajeev Khajuria
Integrated Resources Inc., United States
Quality Assurance Regulatory Affairs, Practice Director