Risk assessment is an attempt to answer the following
– What can go wrong?
– How bad are the consequences?
– How often does/will it happen?
• Probability of Occurrence
– If it happened, how would we know?
• Likelihood of Detection
– Is the risk acceptable?
• Risk Evaluation, Remediation
Risk Management in Pharma/Biotech
– A consensus standard based on sound scientific, engineering and quality principles that separates business risk from patient safety risk
– Focus on product and process design through detailed requirements and mitigating risks in the design phase
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