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The new era of quality risk management:
modern tools for modern risks


Amy Wotawa, Senior Director Global Quality at Pharmatek Solutions Inc

Today’s fast-paced life sciences landscape demands sharper, more adaptive approaches to risk. In this session, Amy Wotawa explores how to apply Quality Risk Management (QRM) principles from ICH Q9 with clarity and intention, using real-world, cross-sector examples. You’ll gain practical methods to strengthen your risk assessments, improve decision-making, and communicate risk more effectively across GxP environments.

 

In this session you will learn how to:

 

  • Apply QRM principles with clarity, intention, and measurable impact.
  • Strengthen your risk assessments with practical, real-world techniques.
  • Use informed decision-making and proactive communication to drive better outcomes across GxP environments.

You’ll leave with modern, actionable tools to elevate your risk management practices and support stronger, more confident quality decisions.