This laboratory compliance training will teach you how to validate an analytical method under the GLP requirements. It will cover in detail the criteria for the validation of an analytical method including statistical and documentation requirements.
Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees validity of results. If you work in pharmaceuticals, chemicals and petrochemicals, and environmental analyses then you are mandated to be following GLP. One of the major tasks in GLP is validation of an analytical method. All methods must be validated. Common criteria are accuracy, precision, linearity, range, and several more.
This webinar will teach you how to validate an analytical method under the GLP requirements.Areas Covered in the Webinar:
This webinar will provide valuable assistance to all personnel working in a GLP certified laboratory and for those developing methods for environmental analysis, chemicals, petroleum products and petrochemicals. Employees who will benefit include:
Consultant, Fetzpahs Consulting
John C. Fetzer, has had over 30 year experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers on liquid chromatography, has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bio analytical Chemistry.
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 a purity of the main component. Each minor contaminant or degradation product is also important in GLP.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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