Quality Risk Management (QRM) – Free PDF download






Risk assessment is an attempt to answer the following
– 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


Download PDF here


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

The text above is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

Also see:



Manostaxx – Industrial Management Consulting

Leave a Reply

Your email address will not be published. Required fields are marked *