Test Method Validation

Practical test method validation training delivered by expert tutors using real industry examples.

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This highly interactive two-day training course provides a practical and structured approach to Test Method Validation (TMV) for physical test methods used in medical device and pharmaceutical manufacturing environments.

The course focuses on ensuring that test methods used to make quality decisions are reliable, repeatable and capable of producing valid results. Through a combination of tutor-led instruction, real industry examples and practical exercises, learners will gain a clear understanding of how to plan, execute, analyse and report on test method validations.

The training covers Gauge R&R and alternative approaches such as Precision to Tolerance, Gauge Capability and Analysis of Variance (ANOVA) for both destructive and non-destructive test methods. The training also covers Attribute Test Method Validation using Attribute Agreement Analysis. The training involves analysis of actual industry examples using statistical analysis software. The highly practical nature of this training gives learners the practical skills and confidence to complete test method validations that are fully compliant with regulatory expectations and industry best practice, allowing compliance with regulations and standards such as 21 CFR Parts 211 and 820, EU GMP Vol. 4, ISO 13485:2016 and ISO 11607.

Note: This course does not cover analytical test method validation (e.g. ICH/USP approaches). If your training need relates to validation of analytical test methods please enquire about our Analytical Test Method validation training programme.

We can customise the training to meet your specific training needs and incorporate your data and examples from your test methods into the training programme as required.

For abbreviations used in this document, see end of document.

Using practical examples, case studies and hands-on exercises, this course guides learners through the full Test Method Validation lifecycle, including planning, execution, statistical analysis and reporting.

The training includes:

Foundations of Test Method Validation

Role of TMV in ensuring product quality and compliance
Differences between validation of processes and validation of test methods
Understanding attributes vs variables and the implications for test method validation
Definition and objectives of Test Method Validation

Measurement Equipment Preparation

Sources of variation: equipment, operator and sample variation
Ensuring the suitability of the measurement system
The need for equipment IQ/OQ
The need for software validation
Electronic Records and Data Integrity requirements

Variable Test Method Validation

Gauge R&R principles and methodology
Study design (sample selection, operators, repetitions)
Interpretation of results (variation, % contribution, study variation)
Acceptance criteria for Gauge R&R

Alternative TMV Approaches

Precision-to-Tolerance (P/T) method
Gauge Capability (Cg)
Process-to-Tolerance concepts
Validation through conformance to recognised standards

Attribute Test Method Validation

Attribute Agreement Analysis
Sampling approaches for attribute testing
Establishing confidence in inspection decisions

Statistical Analysis and Use of Software

Performing TMV analysis using statistical tools such as Minitab^TM
Practical case study in the use of Minitab to perform Gauge R&R Studies
Interpretation of graphical outputs and ANOVA tables
Practical case study in the use of Minitab to perform Attribute Agreement Analysis
Identifying measurement system issues

Protocols and Reporting

Developing TMV protocols with defined acceptance criteria
Executing studies in a controlled manner
Documenting results and drawing valid conclusions
Linking TMV to SOPs and quality systems

The training involves practical exercises covering all relevant topics, with learners encouraged to work on examples from their own workplace as part of these practical exercises. Where requested, content can be customised to reflect your organisation’s specific processes, risk profile, and regulatory setting.

This course is intended for anyone involved in the development, validation, execution or review of test methods used in life sciences manufacturing.

The training is particularly beneficial for those involved in:

Validation Engineering and Quality Engineering
Manufacturing and Production Operations
Laboratory and Test Engineering (Physical test methods)
Quality Assurance and Regulatory Compliance
Technical Services and Process Support
Research and Development

It is also suitable for managers responsible for approving validation strategies or ensuring compliance with regulatory expectations.

A good standard of written and spoken English is important to engage effectively with this programme.

Minitab^TM software will be used throughout the training course. Delegates will need to have Minitab versions 20, 21 or 22.

A 14-day trial version of Minitab 22 software is available on www.minitab.com

On successful completion of the training, learners will be able to:

Explain the purpose and regulatory importance of Test Method Validation
Differentiate between attribute and variable test methods and apply appropriate validation approaches
Apply appropriate validation approaches for both destructive and non-destructive tests
Identify and control sources of variation within measurement systems
Ensure that equipment is suitable and prepared for the TMV study
Develop clear, structured TMV protocols with appropriate acceptance criteria
Run validation studies using appropriate blinding techniques
Avoid common pitfalls when practically running a TMV study
Design and execute Gauge R&R studies for variable data
Apply alternative TMV approaches such as Precision-to-Tolerance, ANOVA and conformance to standards
Analyse TMV data using statistical tools such as Minitab
Perform Attribute Agreement Analysis for pass-fail based tests
Analyse Attribute Agreement Analysis ouput using statistical tools such as Minitab
Interpret TMV results and assess measurement system capability
Produce validation reports that demonstrate regulatory compliance

These outcomes enable learners to confidently validate test methods and ensure that product quality decisions are based on reliable data.

This course is delivered by highly experienced tutors with regulatory and operational expertise in validation. Each tutor brings real industry experience, sector-specific insights and a passion for practical training. Their focus is on building learner confidence through engagement, hands-on exercises and personalised support.

Grainne Heneghan

Grainne is a highly experienced Continuous Improvement and Lean...

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John Lafferty

John Lafferty is a Quality professional with over 25 years expe...

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Noel McCann

With over 30 years experience in applying and coaching Lean &am...

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To consolidate learning and reinforce key concepts, learners complete a post-course assessment.

The assessment;

Checks understanding of the course content and practical scenarios
Assesses real-world understanding and application
Helps to embed and reinforce the classroom learning

Is completed within one week of course completion

Successful learners receive a Certificate of Achievement

Our training approach is practical, highly interactive and discussion-based, with flexibility to meet organisational needs

Pre-training consultation for in-company courses to tailor content to organisational needs
Emphasis on industry specific application through practical exercises, case studies and group activities that reinforce key concepts and encourage active participation.
Access to comprehensive course material that is regularly reviewed and updated to reflect the latest industry standards and guidance.
Live training is available virtually or delivered onsite to suit the needs of the team
Real-time support from expert tutors

Class sizes are generally limited to 12-15 participants to support personalized learning and individual support.

Learners who complete this course often continue to deepen their skills in:

Process Validation and Equipment Qualification
Statistical Process Control
Statistics with Minitab
Software Validation
Electronic Records & Electronic Records and Data Integrity
Risk Management (ISO 14971 or ICH Q9)
Technical Writing Skills

ATMV: Attribute Test Method Validation
ANOVA: Analysis of Variance

Cg: Gauge Capability Index
Gauge R&R: Gauge Repeatability and Reproducibility
IQ/OQ: Installation and Operational Qualification
MSA: Measurement System Analysis
P/T: Precision to Tolerance
QA: Quality Assurance
R&R: Repeatability and Reproducibility
SOP: Standard Operating Procedure
SPC: Statistical Process Control
TMV: Test Method Validation

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Snapshot

Online Learning FAQ >

Course Code

LS051

Duration

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Public Price

Virtual Training: €745

Delivery Mode

This programme is delivered by Virtual Training, or In-Company training

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