LC-MS/MS: Bioanalytical Method Validation

Next Course

10-Hour Live Stream or On-Site

2026 Course Dates will be available soon. Please join the wait list or if you have more than 10 who need training we can provide on-site course customization and delivery details.

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Course Fee

$1650.00 Regular Registration

$1450.00 Early Bird Pricing (Register 30 Days in Advance)

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Future Live Stream Sessions (click to register)

This intensive 10-hour short course offers comprehensive, practical LC-MS/MS bioanalytical method validation training specifically designed for practicing scientists within the pharmaceutical industry. 



Understanding and performing bioanalytical method validation for pharmaceutical studies is essential to the successful execution of nonclinical, biopharmaceutics and clinical pharmacology studies, ensuring data integrity and regulatory compliance.

Course Description

This course will provide an in-depth exploration of bioanalytical method validation, with a specific focus on liquid chromatography mass spectrometry validation techniques. 


Participants will be guided step-by-step through the foundational concepts and advanced bioanalytical method validation techniques required to validate bioanalytical methods. A strong emphasis will be placed on developing critical problem-solving skills through real-world examples and case studies frequently encountered in the demanding pharmaceutical industry environment. This makes it an ideal LC-MS/MS validation course for pharmaceutical scientists.


Participants will gain essential insights from the latest FDA guidance on bioanalytical method validation. The curriculum is crafted to address the practical challenges and nuances associated with bioanalytical method validation, moving beyond theoretical knowledge to practical application. 



Upon successful completion of this course, participants will have the confidence and expertise to validate their own bioanalytical methods independently. The course will also cover the application of validated methods for routine assay procedures and present typical case studies to solidify understanding and best practices.

Who Should Attend

This focused short course is invaluable for professionals seeking to enhance their expertise in bioanalytical method validation for pharmaceutical studies and regulatory compliance. It will significantly benefit:



  • Analytical chemists: Deepen your technical skills in LC-MS/MS validation and troubleshoot complex issues.
  • Lab supervisors: Gain comprehensive knowledge to oversee validation processes and ensure compliance within your team.
  • QA/QC managers: Strengthen your understanding of validation requirements to optimize quality assurance and control systems.
  • Regulators: Enhance your ability to evaluate submissions and ensure adherence to current guidelines.
  • GLP auditors: Acquire detailed insights into validation practices for more effective auditing in GLP-regulated environments.
  • CRO consultants: Expand your service offerings and bioanalytical validation expertise to meet diverse client needs.
  • Management professionals: This course serves as an excellent refresher, enabling you to stay current with evolving GLP regulations and the critical role of bioanalytical validation in drug development.


Register for the LC-MS/MS Bioanalytical Method Validation Course

The LC-MS/MS Bioanalytical Method Validation course takes you through essential topics such as validation guidelines, the purpose of validated methods and proper sample handling. It also helps you develop the necessary skills to design validation tests, evaluate results and report data.



Register for an upcoming course or join our wait list to enhance your understanding of bioanalytical method validation.

Join The Wait List Request On-Site Details

  • Learning Objectives

    At the end of this course attendees will:

    • Learn the essential concepts from the Bioanalytical Method Validation, Guidance for Industry.
    • Apply the concepts to practical issues associated with the bioanalytical method validation.
    • Be able to independently validate their own bioanalytical methods. 
    • Apply the validated bioanalytical methods for routine assay.
    • Learn how to deal with matrix effects and complicated biological samples.

  • Agenda

    Section 1.  Validation guidance/guidelines

    • ICH
    • AOAC
    • IUPAC
    • Eurachem
    • EMA
    • FDA
    • SANCO
    • Nordtest guide for measurement uncertainty

    Section 2.  What can the validated methods answer

    • Does the method measure the intended analyte? 
    • Does anything interfere with the measurement?
    • Is the method specific or selective for the analyte?
    • What is the variability associated with these measurements? - what are the accuracy and precision of the method?
    • What is the LLOQ? What is the ULOQ?
    • How do sample collection, handling, and storage affect the reliability of the data 
    • Do the samples need to be frozen during shipping? 
    • What temperatures are required to store the samples, and how long can the samples be stored?

    Section 3:  Bioanalytical method validation

    • How to design an accuracy & precision run
    • What are the acceptance criteria for an A&P run
    • Requirements for accuracy, precision, recovery, selectivity and specificity
    • How to design a calibration curve - LLOQ, ULOQ and weighting factor
    • How to prepare quality control (QC) samples
    • Acceptance criteria for standards and QCs 
    • How to design selectivity and specificity tests
    • How to design matrix effect and recovery tests
    • How to design dilution effect tests
    • How to design stability tests for autosampler, benchtop, extracted samples, stock solution and long-term storage
    • When do I need partial or cross validation
    • How to report bioanalytical method validation

    Section 4:  Apply the validated methods for routine bioanalysis 

    • Recommendations for routine drug analysis
    • Design an analytical run/batch
    • How to arrange samples - by subject or by period?
    • Evaluation of LLOQ, ULOQ and QCs
    • Criteria to approve or reject results
    • Evaluation of unknown study samples
    • Deviations and remedial actions
    • Re-assay and incurred sample reanalysis (ISR)
    • How to select re-assay results
    • How to report bioanalytical data 

    Section 5:  Case studies and GXP discussion

    • Validation bottleneck and challenges 
    • How to measure and minimize matrix effects
    • How to harmonize the various global bioanalytical guidance documents
    • How to deal with urine samples
    • How to improve the throughput

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.