Webcast PharmTech: CCI Testing and the Revised EU Annex 1

The final EU Annex 1 revision on manufacturing of sterile medicinal products is expected to be released soon. The new language will likely have an impact on container closure integrity (CCI) testing practices. Regulators are paying closer attention to the proper design of robust CCI studies, validation of CCI testing methods, and the generation of statistical data. This webcast will cover:

  • Changing regulatory requirements
  • CCI testing strategies
  • Validation of CCI testing methods
  • CCI testing on statistical sample sets
  • Industry case study examples

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