Ensuring data quality and addressing chromatographic challenges in routine pharmaceutical analysis: Tools for Success

Inspired by a suite of new ICH guidelines, chromatographers are now managing methods using a lifecycle approach to improve the consistency, ruggedness and quality of separations to enable right-first-time analyses. Development and deployment of these analytical methods to modern, routine-use HPLC platforms mitigates the risk of invalidated data, continually adjusted or manual peak integration, and system suitability failures.

Learning Objectives:

• Current trends in regulatory observations referencing chromatography analyses
• How new ICH guidelines will influence how chromatographic methods are developed and documented, resulting in more stringent system suitability and reproducibility requirements
• How improvements in the performance and ruggedness of HPLC instruments can improve data quality

Presenter: Heather Longden (Senior Marketing Manager, Pharmaceutical Intelligence, Waters)

After a number of years in training, supporting and selling Waters Software, Heather's current role is as a specialist in compliance to e-record regulations, acting as a resource to the global informatics community at Waters and the users of all Waters informatics products. This involves helping design the compliance into Waters informatics products and services, attending and presenting at specialist conferences, keeping up to date on the latest interpretations and amendments to the regulations and disseminating this information to the Waters field and corporate organizations.

Presenter: Paula Hong (Principal Consulting Scientist, Waters)

Paula Hong is a Principal Consulting Scientist at Waters Corporation in the Systems Design and Development Application Laboratory. She received her Ph.D. in Inorganic Chemistry from The University of Pennsylvania (Philadelphia, PA), focusing on the reactivity of transition metal/silane complexes. Paula has over 15 years’ experience in the area of LC and LC/MS applications, including amino acid analysis, ion-exchange and peptide mapping. She began her career at Waters in the chemistry division focusing on novel column chemistries for biopharmaceutical applications, including studies on the first hybrid sub 2-µm SEC column. Her more recent work has focused on understanding the role of instrumentation characteristics on chromatographic separations. These studies have included method development for both reversed-phase and supercritical fluid applications as well as method transfer. She has authored over 25 journal articles, white papers, and application notes on a variety of chromatographic principles.