ASTM E2500 Validation and Risk

This presentation at BOSCON2024 captures some of my thoughts on risk management in an ASTM E2500 framework and how it drives activities through and beyond acceptance and risk.

I certainly have been thinking a lot of ASTM E2500. It may be 17 years old but frankly I think its still a major work in progress. Good thing it is currently undergoing another revision process under work item WK88043. This revision aims to update E2500-20 to include:

  • Best industry standards
  • Most recent regulatory guidance
  • Current updates to ICH Q9R1
  • EMA Annex 1 and 15 (itself in a revision cycle)
  • Best practices from PDA TR 54-5 on Quality Risk Management

Slides

One could say these slides are part of my wider dialogue with ASTM E2500.

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