Purchase any WEBINAR and get
10% Off
CODE: SAVE10
T&C applicable, please referFAQ
Validity : 01st Jul'25 to 11th Jul'25
The ins and outs of method validation under GLP
- Learning how to assess and choose criteria
- Knowing how to explain these choices during a compliance review
- Learning how to define each criterion and assess its value
- Being able to describe the needed exceptions to these criteria and how to include those in the standard operating procedure
Overview of the webinar
Method validation involves assessing the results of an analytical methodology to prove that it meets all of the requirements that its output, the data, must have. This two-hour presentation covers the intentions of method validation, several of the common criteria found in this process, and the boundaries that each has that are key elements in a compliance review.
In addition to the core criteria of accuracy and precision, each method can have others. The specific choices are not mandated by Good Laboratory Practices (GLP) or ISO 17025, but are chosen and defined by the use of the data. These other criteria may include linearity, selectivity/ specificity, limits of detection and quantitation, robustness and ruggedness, repeatability and reproducibility, range, and stability. In the review of each, the reasons for having or not having each will be covered.
Who should attend?
- Laboratory staff
- Development chemists
- Laboratory supervisors and managers
- Quality officers
Why should you attend?
Any method is unusable unless it is proven to provide data that is suitable. This presentation will connect the end uses of the data to the requirements that the method must provide. Each criterion, when well chosen and assessed, gives the method strength. A well-documented method validation will show an auditor that the laboratory understands both its own operations and the needs of the end users of the data. Additionally, a program of monitoring key operations will be described that ensures on-going quality and prevents out-of-compliance events.compliance events.
Faculty - Dr.John Fetzer
Dr. John C. Fetzer, PhD offers over 20 years of expertise in Analytical Chemistry, focusing on Polycyclic Aromatic Hydrocarbons, Petroleum and its Products, Chromatography, and UV and Fluorescence Spectroscopy. He offers Analytical Chemistry Consulting Services and Scientific Career Development Consulting services to companies, organizations, and individuals. Dr. Fetzer has over a decade of experience as a supervisor, team leader, trainer, and coach. He has published over 100 peer-reviewed scientific publications, 2 books, and 8 book chapters.
Dr. Fetzer is an American Chemical Society tour speaker, who has participated in over twenty invited lectures at conferences, universities, and government laboratories.