HPLC Analytical Method Development and Validation
Master HPLC instrument and method validation to meet US EPA and FDA requirements for pharmaceutical analysis.
Instructor
Dr. John C. Fetzer
HPLC Method Development Expert & GLP Compliance Specialist
What You'll Learn
About the event
Instrumental liquid chromatography is an analysis technique widely used to determine purity, impurities, and degradation products of pharmaceuticals.
The focus of most validation work is on the methodology and the standard operating procedure (SOP). But validation of the instrumentation and other associated items — the column, solvents, reagents and chemicals — is also an area of focus in an audit.
In order to meet US EPA or FDA requirements, a method must meet many stringent requirements. The more important of these are method validation and instrument validation. Failure to do so is a non-compliance in which any data is not usable or reportable.
Code: FDB2324
Curriculum
Requirements
- Basic understanding of laboratory instrumentation
- Experience in pharmaceutical or analytical chemistry environments
- Familiarity with FDA or EPA regulatory requirements is helpful
Who Should Attend
Chemists, Laboratory Assistants, QA Managers and Personnel, QC Managers and Personnel, Validation Specialists, Quality System Auditors, and Regulatory Compliance Associates.
Areas Covered
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 hour
Certificate
Included
Access
Lifetime
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