Ensuring Data Quality and Addressing Chromatographic Challenges in Routine Pharmaceutical Analysis: Tools for Success
Data quality and data integrity are critical in key decisions supporting the safety and efficacy of pharmaceutical products. Regulatory observations in pharmaceutical laboratories routinely cite concerns regarding the suitability of analytical methods, particularly chromatographic methods that require analysts to intervene, adjust or repeat testing.
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.
The webinar hosts will examine key challenges faced in the routine analysis laboratory and demonstrate method transfer to the new Waters Arc HPLC System. The Arc HPLC is designed to receive transferred methods seamlessly and run existing HPLC methods with improved robustness and precision over traditional HPLCs, avoiding system suitability failures and the invalidation of results. The Arc family of LC systems, when paired with appropriate column technology and gold standard, compliant-ready Empower Software, combine to offer robust performance in routine analysis, facilitating data review, eliminating burdensome quality or compliance documentation, and improving the overall quality of laboratory data.
Key learning objectives
- Current trends in regulatory observations referencing chromatography analyses
- How analytical method performance can be a root cause of data integrity concerns
- 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
Who should attend
- Pharmaceutical directors, managers and analysts who wish to ensure data quality in the QC/routine analysis laboratory
Presenter: Heather Longden (Senior Marketing Manager, Pharmaceutical Intelligence, Waters Corporation)
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, PhD (Principal Consulting Scientist, Waters Corporation)
Dr. Paula Hong is a principal consulting scientist at Waters Corporation in Milford, MA. She received her Ph.D. in inorganic chemistry from the University of Pennsylvania (Philadelphia, PA) and began her career as an applications chemist at Waters Corporation over 15 years ago in the area of bioseparations. She has authored numerous journal articles, white papers, and application notes on both LC and SFC techniques. Her more recent work has focused on LC/MS applications, method transfer and method lifecycle management.
Moderator: Finn Price (Editorial Team, SelectScience)
Fionnbhar Price is a member of the SelectScience Editorial Team, who plays a core role in sourcing and publishing content for the site, with a particular focus on the field of applied chemistry. He has an MChem in Chemistry from Cardiff University, UK, and undertook a year in research characterizing bacterial protein.
