Master instrument and method validation for liquid chromatography — meeting stringent US EPA and FDA requirements to ensure every result is usable, reportable, and audit-ready.
Includes live access & recording
Instrumental liquid chromatography is one of the most widely used analytical techniques for determining purity, impurities, and degradation products of pharmaceuticals. Getting the method right requires more than running samples — it demands validated instrumentation, a validated methodology, and documented compliance at every step.
The focus of most validation work is on the methodology — the standard operating procedure (SOP). But validation of the instrumentation and associated items such as the column, solvents, and other reagents and chemicals is also an area of focus in an audit.
In order to meet US EPA or FDA requirements, a method must satisfy many stringent requirements. Failure to validate both the instrument and the method constitutes non-compliance — rendering any data generated unusable and unreportable.
Many laboratories focus validation efforts solely on the SOP while overlooking the equally critical requirement to validate the instrument itself. This gap creates significant regulatory exposure during audits and inspections — where both instrument and method validation are scrutinized.
This session covers both dimensions comprehensively: the pumping system, column, detection, and data systems on the instrument side, and accuracy, precision, linearity, specificity, sensitivity, and solution stability on the method side.
Attend to ensure your laboratory's HPLC operations are fully compliant, audit-ready, and producing data that regulators and auditors will accept without question.
Four focused areas covering the complete validation landscape for HPLC in regulated pharmaceutical environments.
Understand the validation requirements for each component of the HPLC system — pumping, column, detection, and data systems — and what auditors expect to see documented.
Learn the complete set of method validation parameters: accuracy, precision, limits of detection and quantitation, linearity, selectivity, sensitivity, and solution stability.
Understand US EPA and FDA requirements for analytical method validation and how to structure your SOP and documentation to meet them at every stage of the analytical lifecycle.
Identify the common validation gaps that trigger audit findings and learn practical steps to ensure your laboratory's HPLC systems are always inspection-ready.
Two comprehensive validation tracks — instrument validation and method validation — covering every parameter regulators and auditors evaluate.
Laboratory, quality, and compliance professionals in pharmaceutical, biotech, and other regulated industries who develop, use, or audit HPLC analytical methods.
Chemists
Laboratory Assistants
QA Managers and Personnel
QC Managers and Personnel
Validation Specialists
Quality System Auditors
Regulatory Compliance Associates
High-Performance Liquid Chromatography (HPLC) is the analytical workhorse of the pharmaceutical industry, routinely used to assess the purity, identity, and potency of drug substances and products. Its results directly inform release decisions, stability assessments, and regulatory submissions — making the validity of both the instrument and the method a matter of patient safety and regulatory accountability.
Regulatory agencies including the FDA and US EPA have established clear expectations for analytical method validation under guidelines such as ICH Q2(R1), USP general chapters, and 21 CFR Part 211. These requirements extend beyond the method itself to the instruments used to execute it. An unvalidated instrument running a validated method does not produce acceptable data — a distinction that is frequently misunderstood and routinely cited in 483 observations and Warning Letters.
With increasing regulatory scrutiny of laboratory data quality and data integrity, organizations cannot afford to treat validation as a one-time exercise. Understanding the specific parameters that must be validated, how they are measured, and how they must be documented is essential knowledge for anyone operating HPLC systems in a regulated environment. This session delivers that knowledge in a focused, practical format — applicable from the day of the webinar forward.
Dr. John C. Fetzer has been conducting liquid chromatographic method development for over 35 years. His Ph.D. focused on studies of various types of chromatography, providing a deep scientific foundation that has informed decades of practical, regulatory-aligned work in the field.
He has authored or co-authored over 50 papers on LC separations and has served on the advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry — some of the most respected publications in the analytical sciences.
Dr. Fetzer supervised the Good Laboratory Practices (GLP) accreditation of a large research chromatography laboratory and has taught numerous short courses on GLP and ISO 17025 compliance. His combination of scientific depth and regulatory expertise makes him uniquely qualified to guide laboratory professionals through the complexities of HPLC instrument and method validation in regulated environments.
Join Dr. John C. Fetzer for a comprehensive session on HPLC instrument and method validation — and ensure your laboratory data is always usable, reportable, and audit-ready.