Analytical method development: A quality by design (QbD) approach
The quality by design (QbD) approach in analytical method development emphasizes risk management and comprehensive scientific approach. Its application in analytical method lifecycle helps to increase the robustness and ruggedness of methods compared to traditional method development approaches. Furthermore, the United States Pharmacopeia (USP) Chapter <1220> provides the framework for the implementation of QbD principles around analytical method. USP <1220> emphasizes the importance of sound scientific approaches and quality risk management for the development, control, establishment and use of analytical procedures.
In this webinar, Dr. Rajagopal Karuppuswamy, Vice President of analytical servies at Nephron Pharmaceuticals Corporation and Manu Grover, business development manager of pharma markets at Agilent Technologies will discuss the concept of QbD in reference to analytical development, the steps required to implement QbD, recent regulations in this area, and the benefits of adopting QbD.
Key learning objectives
- Learn about the implementation of QbD in research labs and the analytical development process
- Gain insight into improving method robustness and implementing risk assessment approaches during analytical development
- Explore the steps required to comply with regulatory guidelines and the lifecycle management approach
Who should attend?
- Analytical scientists
- Lab managers
- Regulatory experts
- R&D heads
- Quality control scientists/managers
- Quality assurance experts
Certificate of attendance
All webinar participants can request a certificate of attendance, including a learning outcomes summary, for continuing education purposes.