What You Will Learn
At the end of this workshop, participants will be able to:
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Identify why CAPA is required and who requires it
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Develop a risk-based approach to the CAPA process to determine the depth of investigation, CAPA cycle time, and any immediate corrections your organization needs to take
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Describe the benefits of creating a problem-solving culture within the organization
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Create an effective problem statement
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Document CAPA findings
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Differentiate and document known problems versus identifying those problems that require further investigation and CAPA
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Analyze the root cause: Fishbone, 5 Whys
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Verify the root cause, including with logic, trials, and data
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Select, implement, verify, and maintain solutions
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Defend the investigation
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Prepare for an FDA inspection of CAPA
Who Should Attend
Anyone in compliance/regulatory affairs, QA/QC, manufacturing operations and document management, as well as anyone participating in root cause analysis investigations.
Virtual Half-Days:
5
In-Person Full-Days:
3
CEUs:
2.5