Analytical Method Validation under Good Laboratory Practices (GLPs)
Master analytical method validation under GLP — covering statistical requirements, selectivity, stability assessment, reagent comparison, and FDA compliance for pharmaceutical laboratories.
Instructor
Dr. John C. Fetzer
HPLC Method Development Expert & GLP Compliance Specialist
What You'll Learn
About the event
About this event
Good Laboratory Practices training (GLP) is essential to any laboratory that supports products for sale or use in the United States. A central aspect of GLP is validation of an analytical method. Completely new compounds are being developed each day in pharmaceuticals — their properties are unknown, and synthetic reactions may create structural and optical isomers.
The methodologies that warrant US FDA compliance with GLP regulations require being able to separate and identify all major, minor, and trace components. As per GLP requirements, each minor contaminant or degradation product is also important.
This webinar discusses analytical method validation, best practices, components of a validation, critical reagents comparison, selectivity experiments, and the importance of communication between development and validation labs.
Code: FDB3460
Curriculum
Requirements
- Analysts, lab supervisors and managers, QA managers, and validation specialists
- Applicable to chemists, consultants, and regulated laboratory personnel in pharma and biotech
Meet Your Instructor
Dr. John C. Fetzer
HPLC Method Development Expert & GLP Compliance Specialist
Dr. John C. Fetzer has been doing liquid chromatographic method development for over 35 years. His PhD was in studies of various types of chromatography. He has authored or co-authored over 50 papers on LC separations, has served on the advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry. He supervised the Good Laboratory Practices accreditation of a large research chromatography laboratory and has taught numerous short courses on GLP and ISO 17025 compliance.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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