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Full or partial remote GXP inspections by health authorities are a real possibility in this COVID-19 pandemic era where physical presence is replaced with virtual interactions. Some key components of inspection preparation and conduct have to be considered and adjusted to ensure inspections proceed goes smoothly. Delays due to poor planning can be costly on so many levels. This session will highlight a few of the most important areas where traditional process and plans have to transition to ensure seamless execution. During this presentation, the following topics will be reviewed

  • Planning for the remote inspection – create an remote inspection plan
  • Sitting in a physical space is no longer  -  how to transition to virtual  
  • Realizing the Impact to all the person to be involved in the inspection – change is difficult
  • Investing in assessments of the processes and systems support inspections  
  • Testing that the revised inspection with a mock audit