Paradigm Shift in Analytical Development and Quality Control

The implementation of new, efficient and adapted analytical procedures is a pressing need for the development and release of innovative new pharmaceutical products to ensure their efficacy and patient safety. The growing interest in complex drug modalities (small molecules, Biologics, ATMPs) demands ever more sophisticated analytics, while the rapidly evolving regulatory landscape calls for more advanced, technology- and data-driven approaches. This transformation involves all actors of the biopharma industry, from major pharmaceutical companies to CDMO and testing laboratories. New, agile, sustainable and integrated QC solutions are required to address these new challenges without compromising efficiency.

Webinar Overview

With the recent regulatory emphasis on deep analytical procedure understanding and life cycle management promoted by the Analytical Quality by Design framework, a shift from traditional quality control (QC) procedures to modern analytical approaches and technologies is required. While placing a strong focus on robustness and risk management, the recent ICH Q14 and revision R2 of ICH Q2 also introduce the concept of platform procedures, formally allowing flexibility and agility in the management of analytical procedures. Among these modern technologies, Nuclear Magnetic Resonance (NMR) stands out, able to address multiple needs, from raw material testing to finished products with inequivalent robustness and transferability. By relying on universal and intrinsically quantitative principles, NMR allows straightforward development and risk management, while technology-inherent justifications enable simplified validation, as highlighted in ICH Q2 (R2).

What to Expect

Learn how NMR provides modern and robust solutions for QC, from early development to manufacturing environment. Discover how GMP-compliant end-to-end solutions based on NMR can address a wide range of qualitative and quantitative applications, from raw material testing to the control of critical quality attributes of high-value finished products, constituting an attractive alternative to traditional technologies.

Key Learning Points

• Modern QC labs need advanced, integrated solutions to handle complex drug analytics and evolving regulations efficiently.
• New regulatory framework introduced with ICH Q14 and Q2 (R2) emphasizes robust yet flexible QC procedures, requiring technologies like NMR for effective risk management and validation.
• GMP-compliant NMR solutions offer robust, versatile QC applications, from raw material testing to high-value product quality control.

Who Should Attend

• Innovation or scientific directors, analytical science experts and QC laboratory managers exploring new analytical solutions to solve their current analytical challenges, and address evolving regulatory requirements.
• Analytical scientist involved in CMC and QC procedure development and implementation seeking to discover how NMR can streamline their development and validation workflows.
• Scientist involved in regulatory affairs learning about implementation of modern QC technologies to fit recent regulation.