AQbD Symposium - Day 3 - OOS Reduction in QC Labs Using AQbD and Method Monitoring

AQbD or Analytical Quality by Desgin is a new approach to analytical method development that “starts with the end in mind”.

Exploring experimental conditions and using statistical tools to search for a suitable set of conditions until the method is stable and quality goals are met, are the key success factors for this enhanced approach.

Regulators welcome this science and risk-based approach as described in several upcoming guidelines from ICH, USP, and BP.

Using the preferred language of regulators when filing applications for both small and large molecules, synthetic or biological drugs can significantly reduce the time-to-market.

Join us on Monday, November 29th and hear from many experts in the Pharma arena on how to increase your knowledge around the analytical procedure and minimize the risk of OOS results.

Day 3 - OOS Reduction in QC Labs Using AQbD and Method Monitoring

If the analytical procedure is developed using an AQbD approach its transfer to the QC lab is much simpler but not completely risk free. Assessing the differences between the R&D and QC’s LC instruments and mitigating the risk of the most impactful differences is a key element. In addition, developing a suitable replication scheme can help with assessing and understanding the major source of variability even for methods developed through a traditional approach. The performance of the method needs to be monitored over time and Empower has built-in features to enable this.

15:05 –15:25 (CET): Instrument Comparability using QbD Principles: A tool towards Successful Migration of Validated Procedures

Presenter: Pauline McGregor, Ph.D. (Founder, PMcG Consulting)

Pauline McGregor Ph.D. CChem MRSC founded PMcG Consulting in September 2006. She has over thirty years’ experience in the Pharmaceutical industry and holds a PhD in chemistry. She originally came to Canada from Edinburgh, Scotland in 1995 to carry out her postdoctoral studies at the University of Western Ontario. Pauline is currently a member of the Royal Society of Chemistry, UK and is listed on the RSC Directory of Consultants. She was also member of the original USP expert panel for Validation, Verification and Transfer of Analytical Procedures and a member of a USP Chemical Medicines expert committee.

Pauline is an expert in quality systems and procedures, GMP regulations and analytical chemistry. Her experience in these roles has enabled her to become involved in troubleshooting and improving manufacturing processes (mainly of solid dose forms) through her validation programs, phase 2 investigations of OOS results, evaluation of changes/improvements to the process, assess the impact of these on the product/patient and propose and execute necessary revalidation criteria.

15:25 –15:45 (CET): An Example of Replication in a QC test

Presenter: Michael Lauridsen (Senior Specialist in the Corporate Product Quality Control group, H. Lundbeck)

Currently Senior Specialist in the Corporate Product Quality Control group at H. Lundbeck, working with applied statistics, process validation, spectroscopy and chromatography. Previously , Ph.D. in analytical chemistry and chemometrics from University of Pharmaceutical Sciences, Copenhagen, Denmark, followed by 3 years of Post. Doc positions.

15:45 –16:05 (CET): Software Tools for Monitoring Method Performance and Data Trending

Presenter: Neil Lander (Principal Product Manager, Informatics, Waters Corporation)

Neil has worked for Waters Corporation since 1994 and has held a variety of positions including Technical Support Specialist, Technical Trainer, Manager Customer Education and currently, Principal Marketing Manager focusing on Informatics solutions. He provides internal support for Empower Chromatography Data System and is focused on developing laboratory software solutions that help organizations achieve their scientific and operational objectives. Prior to joining Waters, he was an analytical chemist where he gained experience in both the cosmetics and specialty chemical industries.

16:05 –16:30 (CET): Live Q&A with all Panelists

Moderator: Isabelle Vu Trieu (Americas Pharmaceutical Market Development Manager, Waters Corporation)

Isabelle Vu Trieu is the Americas Pharmaceutical Market Development Manager at Waters Corporation.