Consulting - Process Risk Assessment
Aveta, as a methodology driven company with a toolkit of Lean & Six Sigma processes, has many years of proven success at problem solving from a risk based approach. Following are some examples of regulatory, analytical & quality approaches utilized by Aveta’s team of experts:
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Global types of Risk: |
Business/financial/human factors |
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Pharmaceutical GMP Risk: |
Contamination, environmental conditions, inadvertent chemical transformation of product reactivity / additive / absorptive, sanitation, calibration, validation |
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Availability Risk: |
Personnel, Raw Materials / API, Funding, Business Capacities, Quality System |
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Measurement Error Risk: |
Validity, Resolution/Discrimination, Bias, Stability, Linearity, Process risk |
Following tools are applied for risk assessment:
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HACCP - Hazard Analysis and Critical Control Point |
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FTA - Fault Tree Analysis - Top Down Approach |
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FMEA - Failure Mode and Effects Analysis |
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FMECA - Failure Mode and Effects and Criticality Analysis |
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