Академический Документы
Профессиональный Документы
Культура Документы
Topics to Be Covered
What is CAPA? Governing authority Five steps to a good CAPA process Where companies have difficulty Example citations Recap
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What Is CAPA?
Corrective Action eliminate detected nonconformity Preventive Action prevent nonconformity occurrence
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action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems; (4) Verifying or validating the corrective and preventive action to ensure actions are effective;
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Review: PA does not work Implement: CA wrong Identify: Problem but not root cause
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CAPA Subsystems
MRB
COMPLAINTS MANAGEMENT REVIEW TRAINING CHANGE CONTROL RECALL
OOS
VALIDATION
CAPA
TRENDING AUDITS
APR DEVIATIONS
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CAPA Subsystems
MRB
COMPLAINTS MANAGEMENT REVIEW TRAINING CHANGE CONTROL
OOS
VALIDATION TRENDING AUDITS RECALL
APR DEVIATIONS
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Example Citations
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Analyze
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Analyze
Analyze
Analyze
Analyze
RECAP
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Recap
LACK OF ROOT CAUSE ANALYSIS
CAPA Subsystems
MRB
COMPLAINTS MANAGEMENT REVIEW TRAINING CHANGE CONTROL
OOS
VALIDATION
CAPA
APR DEVIATIONS
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Questions?
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