CAPA and Risk Management

A session at Quality Management Systems for the BioPharma Cold Chain

  • Mary Mazur-Melnyk

Thursday 19th April, 2012

11:00am to 11:00am

* Implementation of the Quality System
* Deviations in the supply chain
o Temperature monitoring techniques
o Defect simulation
* How to access deviations
o Risk Assessment and root cause analysis
+ Product impact
o Risk control approaches
+ Corrective and Preventative Actions
o CAPA Effectiveness
+ Risk review, data collection and assessment of current validation state
+ Risk management strategies to prevent temperature excursions

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Mary Mazur-Melnyk

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When

Time 11:00am11:00am UTC

Date Thu 19th April 2012

Short URL

lanyrd.com/spgfb

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