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ICH M10 Bioanalytical Method Validation and Study Sample Analysis Course & Certification
Intermediate
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4.7
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3 hours
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ICH M10 Bioanalytical Method Validation and Study Sample Analysis
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About
ICH M10 Bioanalytical Method Validation and Study Sample Analysis training provides a comprehensive understanding of the principles and regulatory expectations for validating bioanalytical methods and analyzing study samples in pharmaceutical and clinical research. It emphasizes reliable, reproducible, and scientifically sound bioanalytical data, with a strong focus on method performance, sample analysis, data integrity, and inspection readiness.
This ICH M10 Bioanalytical Method Validation and Study Sample Analysis Course & Certification covers key areas including bioanalytical method development and validation, calibration standards and quality controls, accuracy and precision, selectivity, stability, carryover, dilution integrity, incurred sample reanalysis (ISR), chromatographic data review, reintegration, audit trails, deviations, failed runs, reagent management, study sample analysis, documentation, and bioanalytical reporting. Upon successful completion, learners receive a certification demonstrating their understanding of ICH M10 requirements and best practices for generating reliable and compliant bioanalytical data.
Who Should Enrol?
- Bioanalytical Scientists and Laboratory Analysts
- Bioanalytical Method Development and Validation Professionals
- Clinical Pharmacokinetic and Bioequivalence Professionals
- Quality Assurance and Quality Control Professionals
- Clinical Research and Laboratory Personnel
- Regulatory Affairs and Compliance Professionals
- Data Reviewers and Laboratory Auditors
- Anyone responsible for bioanalytical method validation, study sample analysis, data integrity, and regulatory compliance
What you will learn
Understand the principles and regulatory expectations of ICH M10 for bioanalytical method validation and study sample analysis.
Learn the requirements for selectivity, accuracy, precision, calibration models, stability, carryover, dilution integrity, and quality control samples.
Develop knowledge of incurred sample reanalysis (ISR), chromatographic data review, reintegration, audit trails, deviations, failed runs, and data integrity.
Gain understanding of bioanalytical reporting, documentation, inspection readiness, and best practices for generating reliable, reproducible, and scientifically sound bioanalytical data.
Course Syllabus
- Context - why ICH M10 matters for regulated bioanalysis
- Audience - who this course is for
- Outcomes - what you will be able to do
- Roadmap - the eight lessons
- Two fictional case programmes (small-molecule LC-MS/MS and monoclonal-antibody LBA)
- How you will learn
- Purpose and scope of ICH M10
- Determining what is in scope
- Chromatographic versus ligand-binding approaches
- The bioanalytical lifecycle end to end
- Calibration standards, QCs and study samples
- Full versus partial versus cross-validation - orientation
- Defining the intended purpose
- Characterising the analyte and matrix
- Method development strategy
- Designing calibration standards and QC samples
- Selecting parameters to validate by method type
- Endogenous analytes and rare or limited matrices
- Data-integrity by design
- Selectivity and specificity
- Matrix effect and recovery
- Calibration curve, range and sensitivity (LLOQ-ULOQ)
- Accuracy and precision criteria
- Carryover and reinjection reproducibility
- Dilution integrity
- Stability programme
- Calibration curve and appropriate regression
- Selectivity, specificity and matrix effects
- Accuracy, precision and sensitivity
- Minimum required dilution (MRD) and dilution linearity
- Parallelism
- High-dose hook effect
- Critical-reagent controls and plate/run acceptance
- When full validation is required
- When partial validation is required
- When cross-validation is required
- Method transfer between sites and CROs
- Multiple-analyte methods
- Documenting equivalence
- Run-acceptance criteria during study analysis
- Calibration and QC performance in-study
- Managing failed analytical runs
- Reinjection versus repeat analysis control
- Sample-chain integrity and validated storage
- Avoiding testing into compliance
- Purpose and design of ISR
- Conducting ISR
- Evaluating ISR: +/-20% (chromatographic) and +/-30% (LBA)
- ISR versus validation QCs
- Reviewing chromatographic data
- Reviewing ligand-binding assay data
- Managing deviations and data-integrity risks
- Validation reports
- Study bioanalytical reports
- Quality assurance oversight
- CRO and sponsor responsibilities
- Data-integrity and ALCOA+ expectations
- Inspection readiness
- Consolidating the ICH M10 lifecycle
- Reinforcing the verified acceptance criteria
- Key distinctions to carry forward
- Course complete
- 📘 Bonus: ICH M10 Bioanalytical Method Validation and Study Sample Analysis Training eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with ICH M10 (adopted 2022) and its ongoing Questions & Answers, together with FDA and EMA implementation of the guideline and related regional requirements, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content reflects hands-on regulated-bioanalysis and DMPK expertise across chromatographic (LC-MS/MS) and ligand-binding assay platforms, so that learners can apply ICH M10 correctly in validation, study sample analysis and inspection settings.
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