Establishing Critical Process Parameters, Acceptance Criteria and HealthLimits

Presented by: Cindy Duhigg, Global Validation Steward, Alcon • Application of QbD for cleaning validation• Recognition that acceptance criteria are NOT goals• Determining what qualifies as a “toxicological evaluation”?• Discerning order from the chaos of all the health-based acronymsTakeaway Tools• Case study: Establishing formal health-based exposure limits

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Presented by: Cindy Duhigg, Global Validation Steward, Alcon • Application of QbD for cleaning validation• Recognition that acceptance criteria are NOT goals• Determining what qualifies as a “toxicological evaluation”?• Discerning order from the chaos of all the health-based acronymsTakeaway Tools• Case study: Establishing formal health-based exposure limits
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  • Email: info@kenx.org
  • Phone: 858 649 3251
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