HPLC Instrument Qualification and Method Validation

HPLC instrument qualification and analytical method validation are two related topics that are essential to compliance in regulated laboratories. This webinar will provide details of current regulatory guidance and examples of best practice in each of these areas. The information provided will enable you to assess the level of instrument qualification compliance in your laboratory and identify any gaps, as well as helping you to successfully plan and execute a method validation exercise.

Areas Covered in the Session :

HPLC Instrument Qualification

  • Regulatory guidance
  • Design, installation, operational and performance qualification
  • Performance qualification tests
    • Degasser
    • Pump
    • Sampler
    • Column oven
    • Detector
    • Data system

Method Validation

  • Regulatory guidance
  • Phase-appropriate method validation
  • Experimental approaches
    • Specificity
    • Linearity/range
    • Accuracy
    • Precision
    • Sensitivity
    • Robustness

Who Should Attend:

  • Research and Development Departments
  • Quality Control Departments
  • Quality Assurance Departments
  • Laboratory Professionals
  • Validation Teams
  • Every staff responsible for HPLC equipment qualification and method validation

FDB2601

Dr. Mark Powell

Mark Powell set up Mark Powell Scientific Limited to provide technical support for pre-clinical drug development, which may involve short-term help with specific problems or management of the analytical aspects of a development project, for new or existing compounds, as part of a multi-disciplinary team. He has an expertise in analytical method development and validation (including assay of impurities), design of stability testing studies and auditing of contract laboratories. Mark is also an experienced quality auditor, and can perform GMP audits of contract laboratories, including evaluation of compliance with data integrity requirements.

He also provides training services, which are accredited by the UK’s vocational skills agency, Cogent SSC, and are designed to ensure that analysts have the necessary theoretical and practical skills to perform their jobs competently. As well as courses in instrumental chemical analysis, He also provides training in basic laboratory skills and technical writing (analytical methods, SOPs and technical reports). Mark has recently been working with Spectroscopy Magazine to write and deliver an on-line training course in UV spectroscopy and has also been asked to provide training on behalf of the chromatography consumable company Hichrom.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.