Quality Risk Management (QRM) – Free PDF download

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Risk assessment is an attempt to answer the following
questions:
– What can go wrong?
• Risk
– How bad are the consequences?
• Severity
– 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

ASTM E2500-07
– 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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Continue at: http://www.ispe-casa.org/sites/default/files/effective%20implementation%20of%20a%20risk%20management%20program%20jan%2029,%202013.pdf

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