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Quality Assurance : Audit And Inspection

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prashanth

Quality assurance is the responsibility of the sponsor to ensure clinical trials are conducted properly according to regulations. It involves implementing quality control systems and allowing audits and inspections. Audits independently check that the study, data, patient safety, and regulatory compliance are accurate. Inspections allow regulatory authorities to review documents, facilities, and records. Proper preparation is key, such as having all required documents organized and understanding the protocol. Mistakes are common but can be prevented by understanding good clinical practice principles and having open communication.

EducationTechnologyBusiness
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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
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  • 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
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  • 9. How to Prepare for Audit
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