Analytical Method Development under ICH Q14 Part 2

After the approval of the final version of ICH Q14, dealing with the Analytical method development and the new update of the ICH Q2, analytical validation, incorporating the AQbD concept to the analytical testing, it’s becoming difficult to generate results at the same pace as we have done historically. However, these changes give the developers a powerful tool that assures the ruggedness and reliability of the analytical method.

In both webinars we will review, with our partner Chromsword, the chance to incorporate the new requirements proposed in the quality guidelines in the LC method development workflow, along with the automation possibilities. Easing the analytical and statistical effort in an unprecedent manner.

During this webinar, the second in a two part series, we will share examples of use. Both from the real implementation in a pharmaceutical lab, and an example of complex development upon lipidic nanoparticles composition.

Presenter: Dr. Aline Bayerle (Applikationsspezialistin für LC basierte Lösungen, Agilent Technologies)

Aline works as an application specialist for LC based solutions at Agilent. During 10+ years of working as an analytical chemist in both the pharmaceutical industry, a GLP/cGMP environment, and at Agilent, she was able to gain experience in a variety of applications.