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Key Elements of HPLC And UPLC Mehtod Validation To Ensure Compliance With FDA And ISO Requirements

This course strengthens the ability to validate HPLC and UPLC methods with documented control over instrumentation, precision, detection limits, and data integrity expectations required for GLP and ISO 17025 environments. This Course is designed for professionals responsible for chromatographic method reliability, laboratory compliance, and analytical consistency.

REGISTER FOR THE COURSE

US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Dr. John C. Fetzer
  • Study time : 60 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3461
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

HPLC and UPLC methods are routinely used to assess pharmaceutical purity, impurities, and degradation products, making method validation a critical laboratory responsibility. Regulatory assessments do not focus solely on analytical procedures; instrumentation, columns, solvents, reagents, and supporting systems are also reviewed for suitability and control. Laboratories operating under GLP or ISO 17025 requirements must demonstrate that chromatographic methods consistently perform within established parameters and are supported by documented validation practices.


Attention to pumping systems, detection systems, and data systems is essential when establishing compliant liquid chromatography methods. Validation measures such as accuracy, repeatability, reproducibility, ruggedness, robustness, linearity, sensitivity, and solution stability directly affect analytical reliability and inspection readiness. Careful evaluation of selectivity, specificity, interferences, and quantitation limits helps laboratories identify weaknesses before they become audit findings or compromise reported results. These controls support consistent laboratory performance across routine pharmaceutical testing and regulated analytical environments globally.

  • Strengthen Method Validation Decisions:

    Clear understanding of instrument qualification and chromatographic method validation improves confidence in analytical results during routine testing and audits. The course connects operational factors such as pumping systems, columns, detectors, and data systems with validation performance measures, helping laboratories reduce inconsistencies that can delay investigations or raise compliance concerns.

  • Improve Analytical Reliability Under GLP and ISO 17025:

    Accurate evaluation of precision, detection limits, specificity, sensitivity, and solution stability is necessary for laboratories supporting regulated pharmaceutical work. This training clarifies how these validation elements affect method suitability and long-term reproducibility, providing practical context for maintaining reliable chromatographic performance when inspection expectations extend beyond written procedures alone.

Key Areas Covered

  • Validation requirements for HPLC and UPLC methods in GLP and ISO 17025 laboratories
  • Qualification and validation considerations for chromatographic instrumentation
  • Performance assessment of pumping systems, columns, and detection systems
  • Data system controls supporting compliant analytical operations
  • Accuracy and precision measurements, including repeatability, reproducibility, ruggedness, and robustness
  • Detection limits, quantitation limits, linearity, and sensitivity evaluation
  • Selectivity, specificity, and interference assessment during method validation
  • Solution stability considerations affecting analytical reliability

Who Must Attend

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

Quality training, expert insights, and answers that matter. Know your Expert

Dr. JOHN C. FETZER

Dr. John C. Fetzer has more than 35 years of experience in liquid chromatographic method development, supported by doctoral research focused on chromatography techniques. He has authored or co-authored over 50 publications on LC separations and has served on advisory boards for major analytical science journals. His experience supervising GLP accreditation for a large research chromatography laboratory and teaching ISO 17025 and GLP compliance courses directly aligns with chromatographic method validation and laboratory compliance requirements.

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Our students love us ❤️

“Examples were relatable. Not generic. We could map it to what we are currently doing.”

Supervisor, Quality Control

“Slides were clear. No clutter. That made it easier to stay focused.”


Analyst, QA

“Good overview but still detailed where needed. That balance is not easy.”

Manager, Manufacturing

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