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Course Director

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Course Fee

$1650.00 Regular Registration

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

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Course Brochure

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Course Description

This 10-hour short course is designed to offer practical training for the practicing scientists in the pharmaceutical industry. Validation of bioanalytical methods is crucial for the successful conduct of nonclinical, biopharmaceutics, and clinical pharmacology studies. This short course will focus on the bioanalytical method validation using LC-MS/MS. It will take the participants step-by-step through the concepts and techniques to validate bioanalytical methods. It also emphasizes problem-solving skills with real examples and case studies encountered in the pharmaceutical industry.


The participants will learn essential concepts from the Guidance for Bioanalytical Method Validation issued by FDA. The emphasis is on practical issues associated with the bioanalytical method validation. After this course, the participants will be able to independently validate their own bioanalytical methods. How to apply the validated methods for routine assay and some typical case studies will be presented as well.

Who Should Attend

This short course will benefit the analytical chemists, lab supervisors, QA/QC managers, regulators, GLP auditors and CRO consultants who work in the GLP-regulated labs and the pharmaceutical industry.

 

This course will also benefit all levels of management as a refresher course to stay current with the GLP regulations.

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  • 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.