Webinar | January 2, 2019

CCI Testing And Revisions To EU Annex 1

Source: Lighthouse Instruments

The draft of the revised EU Annex 1, on manufacturing of sterile medicinal products, was recently released. At a first glance the changes might seem subtle, however the new language will likely have a significant impact on your 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. In this webinar we will go over CCI testing strategies and the proposed revisions to EU Annex 1.