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Quality Assurance : Audit And Inspection

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Quality Assurance : Audit & Inspection Prashanth Babu. M Principal Consultant
Topics to be discussed ,[object Object],[object Object],[object Object],[object Object]
Quality Assurance is mentioned in ICH-GCP ,[object Object],[object Object],[object Object],ICH GCP 1997
Quality Assurance is responsibility of sponsor ,[object Object],ICH GCP 1997
Who should be involved in QA process Quality of the study Investigators/ team Sponsor Ethics Committee Institution Health Authority Monitor/ study operation team Biometrics team Patients QA team
The Quality Assurance Procedure ? ,[object Object],[object Object],ICH-GCP 1997
Inspection ,[object Object],[object Object]
Why do the authority inspect ? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
How to Prepare for Audit
What are the areas concerned by auditor ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Preparation for Audit ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Essential Documents (1) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Essential Documents (II) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Essential Documents (III) ,[object Object],[object Object],[object Object],[object Object]
Essential Documents (IV) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Major Mistakes ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Problems/ Mistakes ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What needs to be done to prevent mistake ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Summary ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Thank you for your attention ,[object Object]

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Quality Assurance : Audit And Inspection

  • 1. Quality Assurance : Audit & Inspection Prashanth Babu. M Principal Consultant
  • 2.
  • 3.
  • 4.
  • 5. Who should be involved in QA process Quality of the study Investigators/ team Sponsor Ethics Committee Institution Health Authority Monitor/ study operation team Biometrics team Patients QA team
  • 6.
  • 7.
  • 8.
  • 9. How to Prepare for Audit
  • 10.
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.
  • 20.