Analytical design space modeling in accordance with ICH Q12 and proposed Q14: Using a novel approach for in silico method development and robustness assessment
The successful implementation of Analytical Quality by Design (AQbD) workflows across analytical development has become strategically relevant to the pharmaceutical industry. Scientific design space modeling has proven effective in yielding high levels of robustness, critical to successful transfer and routine use of analytical methods across laboratories. AQbD approaches meet ICH guidance on scientific and risk-based analytical procedure development as suggested in Q12 and proposed Q14, including effective regulatory communication and providing the basis for post-approval flexibility.
In this upcoming webinar, hear from Dr. Pankaj Aggarwal, Principal Scientist at Pfizer, as well as Dr. Alexander H. Schmidt and Mijo Stanic, co-founders of Chromicent GmbH, on how automated AQbD modeling can be used as a strategic approach across analytical operations of a large pharmaceutical company and how system-wide implementation using two established software packages for method modeling can allow for seamless automation of the AQbD modeling workflow.
Watch this webinar to learn:
- How to use an automated AQbD approach to achieve consistent performance across the method lifecycle
- How to implement an automated robustness assessment
- How to efficiently report analytical development outcomes
- How to improve laboratory efficiency using time-saving approaches that address complex, labor-intensive method work
- Strategies to obtain post-approval flexibility
Who should attend:
- Method developers involved in developing or optimizing methods
- Subject matter experts in search of ways to automate AQbD workflows across teams
- Researchers involved in the design and audit of analytical procedures
- Managers interested in reducing the cost of poor-quality methods
Certificate of attendance
All webinar participants can request a certificate of attendance, and a learning outcomes summary document for continuing education purposes.