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Basic Issues of Method Validation Compliance under Good Laboratory Practices
- Method Validation
- The criteria for a method – Precision, accuracy, LOD, LOQ, robustness, ruggedness, linearity, and range.
- Statistical requirements – basic statistics of means, uncertainty, and distribution.
- Documentation requirements
- Control charts to monitor compliance
Overview of the webinar
Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees the validity of results. If you work in pharmaceuticals, chemicals, petrochemicals, and environmental analyses then you are mandated to be following GLP. One of the major tasks in GLP is a validation of an analytical method.
The new pharmaceuticals are very often completely new compounds, structures never studied before by chemists. Their properties – such as solubilities and acid-base nature, are unknown. Synthetic reactions may make many similar types of molecules, including structural and optical isomers. The methodologies that mean US Food and Drug Administration compliance with GLP require a separation to be able to separate and identify all major, minor, and trace components. It is no longer just determining the purity of the main component. Each minor contaminant or degradation product is also important in GLP.
Who should attend?
This webinar will provide valuable assistance to all personnel in:
Those working in a GLP-certified laboratory.
Why should you attend?
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.
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.