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

Presenter: Dr. Rajagopal Karuppuswamy (Vice President - Analytical Services, Nephron Pharmaceuticals Corporation, West Columbia, South Carolina)

Dr. Raja Karuppusamy gained his MS in pharmaceutics and PhD in analytical chemistry from the University of Delhi, India. He has over 20 years’ experience in the pharmaceutical industry. He is currently working as the Vice President of Analytical Services with the Nephron Pharmaceuticals Corporation in South Carolina. He has extensive experience with various regulatory agencies such as the Food and Drug Administration, Medicines and Healthcare products Regulatory Agency, and the Brazilian Health Regulatory Agency (Anvisa). He has published over 20 research papers and has contributed toward multiple USP monographs.

Presenter: Manu Grover (Business development manager – Pharma markets, Agilent Technologies)

Manu Grover is a postgraduate in pharmacy from the Manipal Academy, India. He has 21 years of chromatography experience and has worked in pharmaceuticals to support investigational new drug applications, new drug applications and abbreviated new drug application filings. During his career, he has developed and validated analytical methods on HPLC, GC, particle sizing, DSC, pXRD and LC/MS. In his current role he works with the Agilent sales team, regulators and pharmaceutical scientists. He shares market updates, trends and expertise related to Agilent’s portfolio of columns supplies, and helps to ensure scientists select the right solutions for their lab.

Presenter: Blake Forman (Scientific Content Creator, SelectScience)

Blake studied chemistry at the University of Surrey, UK, and further went on to study a master’s in chemistry at the University of Southampton, UK. Blake has previously worked in the Medicines and Healthcare Products Regulatory Agency (MHRA) lab at LGC and as a technical sales specialist for Waters. As a member of the Editorial team, he now plays an integral role in shaping the content on SelectScience.