Webinar Overview
With the publication of ICH Q2(R2) and ICHQ14, the modern Quality by Design paradigm introduced by ICH Q8 for manufacturing is extended to Quality Control (QC). A life cycle, risk-based management approach is now encouraged where quality is built into analytical procedures. This so-called concept of Analytical Quality by Design (AQbD) demands a detailed understanding of all aspects of analytical procedures to further improve confidence and reliability of reportable values, ensuring product quality and ultimately patient safety.
This new, enhanced framework encourages living and agile procedure and calls for modern approaches and technologies. Nuclear Magnetic Resonance (NMR) align perfectly with these new concepts. By relying on universal and absolute principles, NMR can significantly simplify risk-assessment and streamline analytical procedure management. Its benefices from large method operable design region and it is one of the few technologies that allow leveraging the new concept of platform procedures, where testing quality attributes of several products without significant procedure changes is possible. Furthermore, qualifications and monitoring are simplified due to technology-inherent justifications.
This webinar will explore the benefices of using compact, cryogen-free, benchtop NMR for modern, AQbD-oriented QC procedures in both qualitative and quantitative applications. The development of agile yet simple NMR procedures for identification, one of the most performed tests, will be illustrated. Advantages of quantitative NMR (qNMR) for straightforward QC assays procedure development will be discussed through case studies on model drug products. Additionally, the implementation of more traditional compendial testing will be demonstrated. Finally, solutions for fully GMP-compliant testing will be presented, as a critical key for successful integration of benchtop NMR technology into QC laboratories.
September 10, 2024 | 05:00 PM CST
Key Learning Topics
- Benefices of NMR for the development and management of modern quality control analytical procedures
- Implementation of NMR technology in QC laboratories using compact, cryogen-free benchtop NMR spectrometers
- Solutions for GMP compliance of benchtop NMR procedures
Speakers
Dr. Valentin Poirier
Solutions Product Manager BioPharma, Bruker BioSpin
Dr. Fabrice Moriaud
Product Manager for GxP solutions, Bruker BioSpin
