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 3. KEY ELEMENTS OF HPLC AND UPLC METHOD VALIDATION TO ENSURE COMPLIANCE WITH
    FDA AND ISO REQUIREMENTS


KEY ELEMENTS OF HPLC AND UPLC METHOD VALIDATION TO ENSURE COMPLIANCE WITH FDA
AND ISO REQUIREMENTS

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FACULTY: DR. JOHN C. FETZER

Scheduled Date : May 17 2022

Scheduled Time : 11am -  12pm ET



Description

Instrumental liquid chromatography, either as HPLC or UPLC, are common
techniques in laboratories that are widely used to determine purity, the
impurities, and the degradation products of pharmaceuticals.

The focus of most validation work is on the methodology, the standard operating
procedure (SOP). But validation of the instrumentation and other associated
items of column, solvents, and other reagents and chemicals is also an area of
focus in an audit.

For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods
must meet certain requirements. This presentation will cover the key elements to
have a compliant method.

Areas Covered in the Session :

 * Instrument validation
   * The pumping system
   * The column
   * The detection system
   * The Data System
 * Method validation
   * Accuracy
   * Precision and the various measures of precision (repeatability,
     reproducibility, ruggedness, robustness)
   * Limits of detection and quantitation, linearity
   * Selectivity, interferences, and specificity
   * Sensitivity
   * Solution stability

Who Should Attend :

 * Chemists
 * Laboratory Assistants
 * QA Managers and Personnel
 * QC Managers and Personnel
 * Validation Specialists
 * Quality System Auditors
 * Regulatory Compliance Associates



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Method Validation FDA and ISO Live Webinar SOP
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SOP WRITING, TRAINING AND COMPLIANCE IN THE PHARMACEUTICAL INDUSTRY
COMPLAINT HANDLING, MEDICAL DEVICE REPORTING AND RECALLS - POST-MARKET
REGULATIONS TRAINING
VERIFICATION AND VALIDATION - PRODUCT, EQUIPMENT / PROCESS, SOFTWARE AND QMS

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