Analytical Method Development under ICH Q14 Part 1

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 these webinars we are going to 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 the first part of the seminar are going to review the regulatory landscape, and the available tools both from the software point of view and hardware able to automatize the whole process. Actually the combination of the right hardware and software leads to a significant reduction of development times, securing the method’s ruggedness during the process. A process which meets all requirements from ICH Q14 guidelines.

Presenter: Antonio Chana (Product Specialist Liquid Phase Separation, Agilent Technologies)

Antonio Chana, Doctor of Chemical Sciences and product specialist in liquid chromatography. Antonio joined Agilent from the pharmaceutical industry, where he occupied the positions of analytical development manager, quality control manager and laboratory manager. Over the years he has participated in audits of quality and integrity of data with different national and international regulatory bodies.

Presenter: Arturs Kalimulins (Sales Director, ChromSword)

Arturs Kalimulins is the Sales Director at ChromSword, bringing over 15 years of industry experience to the table. Throughout his career, Arturs has collaborated with pharmaceutical companies worldwide to enhance the speed and efficiency of HPLC method development. His background in IT solutions has provided him with a unique perspective on typical HPLC challenges and workflows.

Currently, Arturs is leading the AQbD workflow management project at ChromSword. This initiative aims to develop and deliver tools to analytical laboratories that organize and systemize every step, task, and document in the HPLC method development process.