Clinical Research and GCP Update

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Root cause analysis and CAPAs

• Root cause analysis should be thorough and not be restricted to the first thing that comes to mind … usually lack of training!̶ DIG DEEP • CAPAs are often criticised for being inadequate or lacking detail. • Remember SMART to avoid being ‘wishy-washy’.̶ Specific̶

Measureable̶ Attributable̶ Realistic̶ Time driven

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Washington Monument 5 Why’s

• https://www.youtube.com/watch?v=BEQvq99PZwo

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© Brookwood Global (Canary Ltd) 2021

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