- Date: Apr. 08 - Apr. 10, 2019
- Place: Berlin
- Website: http://molnar-institute.com
This course provides extensive training for the UHPLC method development by modeling under the use of the software DryLab4. Course participants are guided through a comprehensive method development process, starting with basic one-dimensional model calculations and continuing through multi-dimensional (3D) model optimizations. Users learn to develop, adjust, transfer, and improve methods, focusing on decreasing run times while maintaining the desired selectivity. Furthermore, the course teaches participants to systematically develop robust methods with DryLab4 by creating multidimensional models depicting the interaction of up to twelve of influential HPLC parameters, resulting in better communication with regulatory agencies and faster market entry for new drugs.
A part of this course is devoted to the topic Quality by Design in UHPLC method development. UHPLC users want to understand the QbD framework and how it relates to UHPLC method development processes, especially in regards to the submission of new drug applications. Analytical QbD is a modern concept for assuring the quality of a product, and is recommended by regulatory authorities like the FDA. The QbD approach requires a systematic study of the most important factors influencing the quality of a product, and can be successfully adopted into UHPLC method development using DryLab4 software. The course focuses on new approaches for visualizing the so-called “Design Space”, with the goal of gaining more flexibility in routine HPLC applications.