HPLC Calibration Foundation Course

Description

HPLC Calibration Foundation Course

This course provides a foundational understanding of High-Performance Liquid Chromatography (HPLC) calibration in pharmaceutical quality control laboratories. It focuses on ensuring instrument accuracy, system performance, and data reliability through proper calibration practices. Participants will learn how calibration is performed, documented, and maintained in compliance with regulatory requirements to ensure consistent and trustworthy analytical results.

Key Learning Areas

• Fundamentals of HPLC Calibration
  Understanding the purpose, importance, and regulatory expectations of HPLC calibration in pharmaceutical analysis.
• HPLC System Components & Calibration Points
  Overview of key components such as pumps, injectors, detectors, autosamplers, and columns, along with critical calibration parameters.
• Calibration Procedures & Standards
  Step-by-step calibration practices including flow rate, wavelength accuracy, injection volume, detector linearity, and system suitability checks.
• Use of Reference Standards & Solutions
  Preparation, handling, and application of certified reference standards for accurate calibration and verification.
• System Suitability Testing (SST) Integration
  Linking calibration activities with SST parameters to ensure overall system performance and reliability.
• Documentation & Data Integrity
  Proper recording of calibration activities, traceability, logbooks, and compliance with ALCOA+ principles.
• Troubleshooting Calibration Failures
  Identifying and resolving common issues related to instrument performance, variability, and calibration deviations.
• Regulatory Compliance & Good Laboratory Practices (GLP/GMP)
  Ensuring adherence to pharmacopeial and regulatory requirements for HPLC calibration and maintenance.