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The Do's and Dont's of Preparing for a GCP Inspection

C3 Summit: The Do's and Dont's of Preparing for a GCP Inspection (On-Site and Remote)


Presented by: Gillian Gittens, Director eClinical Strategy & Solutions
Co-Presented by: Alia Hawkes, Sr. Director, Clincial Compliance, FibroGen & Trenton Bacolini, Manager, Clinical Compliance, FibroGen

“By failing to prepare, you are preparing to fail.” – Benjamin Franklin

The industry has observed regulatory authorities evolve their inspection expectations in step with the increasing complexity of clinical trials and available eClinical technology, among other variables. With the ongoing pandemic, further changes have emerged as remote inspections have become necessary. Are these remote inspections here to stay?  

This session will look at how to prepare for both on-site and remote inspections so that teams can prepare for whatever the future may hold. Attendees will learn preparation best practices, including:

  • Inspection plans
  • Settings and location
  • Systems access
  • Document requests
  • Inspection agendas
  • Documents and eTMF best practices (What are the inspectors looking for)