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Method Lifecycle Oversight

  • Method validation QA review: Evaluate method validation protocols and reports for compliance with FDA, EMA, and ICH M10 guidelines.

  • Change control support: Help ensure that method changes are scientifically justified and properly documented.

  • Ongoing method monitoring: Assist in trending of QC/QA performance data to flag degradation in assay robustness.

iBio Consulting, LLC. 

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​       Contact me

          

           Joseph Nawrocki

           joe@ibioconsulting.com

           619-246-2583

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