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HPLC Analytical Method Development and Validation

Course is now LIVE. Click below to join the session.

This course helps laboratory and quality professionals evaluate both HPLC method performance and chromatographic system suitability as interconnected compliance requirements, reducing the risk of generating data that cannot be reported, relied upon, or accepted during regulatory review. This Course is designed for professionals responsible for chromatographic methods, laboratory controls, analytical data quality, validation activities, or regulated testing operations.

  • 17 June 2026
  • Eastern Time (US/Canada): 11.00 AM
  • GMT: 3.00 PM
  • 60 Minutes
  • TF2324
  • Dr. John C. Fetzer
  • Live Session + Post-live Continued Learning
  • Live Q&A Included
  • Presentation Handout & Templates
  • Assessment & Certification Included

REGISTRATION OPTIONS

Live session Plus Complimentary 30 Days Streaming access

$290  |  One participant (viewer)

$390  |  Team of up to 5 participants

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REGISTER FOR THE COURSE

US $290 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 $290 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Faculty
    Dr. John C. Fetzer
  • Study time
    60 Minutes
  • Course ID
    TF2324
  • Skill Level
    Intermediate
  • Assessment
    & Certification Included
  • Ask the Expert
    Included

 

Why take this course?

High Performance Liquid Chromatography (HPLC) remains one of the most widely used analytical techniques for determining pharmaceutical purity, impurities, and degradation products. Regulatory expectations extend beyond generating analytical results and include demonstrating that both the analytical method and the supporting chromatographic system perform consistently and reliably. Data generated from inadequately validated methods or instruments may not meet reporting requirements and can create significant compliance concerns.

Effective HPLC programs require attention to both method validation and instrument validation activities. Analytical procedures must demonstrate characteristics such as accuracy, precision, detection and quantitation capability, linearity, specificity, sensitivity, and solution stability. At the same time, critical system components including the pumping system, column, detector, and data system require appropriate validation to support reliable operation. Understanding how these elements work together is essential for laboratories operating under FDA or EPA expectations, where validation deficiencies can affect data acceptability, audit outcomes, and ongoing laboratory compliance.

Validate More Than the Procedure

Many validation programs focus heavily on analytical procedures while giving less attention to the supporting chromatographic system. This course provides practical understanding of how pumps, columns, detectors, and data systems contribute to overall method reliability and why weaknesses in any component can affect data credibility during audits.

Assess Analytical Performance with Greater Confidence

Reliable analytical methods require more than acceptable test results. Participants will strengthen their ability to evaluate accuracy, precision, linearity, detection capability, specificity, sensitivity, and solution stability, helping ensure that validation conclusions are supported by measurable performance characteristics expected in regulated laboratory environments.

Key Areas Covered

  • Validation considerations for HPLC pumping systems and their role in analytical performance
  • Column-related factors that influence chromatographic consistency and reliability
  • Detection system verification and performance expectations
  • Data system validation requirements supporting reportable analytical results
  • Accuracy, precision, repeatability, reproducibility, ruggedness, and robustness evaluation
  • Detection limits, quantitation limits, and linearity assessment
  • Selectivity, interference management, and method specificity considerations
  • Sensitivity evaluation, solution stability, and validation expectations under FDA and EPA requirements

Who Must Attend

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Compliance Departments
  • CSV Professionals
  • Manufacturing Departments
  • Operations Departments
  • IT Systems Professionals
  • Validation Professionals
  • Risk Management Professionals
  • Digital Transformation Leaders
COURSE DIRECTOR

Dr. John C. Fetzer

Dr. John C. Fetzer has more than 35 years of experience in liquid chromatographic method development and holds a PhD focused on chromatography studies. He has authored over 50 publications on LC separations, supervised GLP accreditation activities for a major chromatography laboratory, and delivered extensive training on laboratory compliance, analytical methods, and validation practices.

If you would like to request a Proforma invoice to sign up for this course. please click here

Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

Upcoming Courses

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Built on 20+ years of global regulatory training experience across FDA, EMA, MHRA, and ICH frameworks.
Trusted by professionals across 80+ countries.

Testimonials

This is an upcoming session. Feedback below reflects experiences from similar programs delivered by our expert faculty.

“Session was easy to follow even for non-core team members. That helped.”
- Production Officer
“Good balance. Not too basic, not too deep. Worked well for mixed team.”
- Manager, Regulatory Affairs
“Team found it useful. Especially for aligning understanding across functions.”
- Director, Operations

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