objectives
Identify the parameters to consider in analytical method validation
Train in the different analytical techniques
Identify existing standards for analytical method validation in the laboratory
Learn how to establish method validation
Teaching methods
- Presentation of the training materials
- Distribution of the training materials
- Training led by experts in the requested techniques
Target audience
Technicians or engineers in charge of research & innovation, process & industrialization, production & maintenance, quality control, hygiene, safety & environment, purchasing & procurement …
Program
- Reminder of the lifecycle of a method
- Define the objectives, choose the method,
- Development
- Pre-validation and validation
- Post-validation
- Monitoring method performance
- Method validation
- Standards
- Validation parameters
- Calibration function; assessment and study
- Limit of quantification
- Method accuracy
- Validation protocol, test execution, data processing, validation file
- Estimation of measurement uncertainties; approach and criteria
- Application to your methods
Information updated on 09.10.2024
Practical information
- In-house training
- Questionnaire at the beginning and end of the training (quiz)
- Attendance sheet
- Duration: 2 days
- Accessibility for PRM and PWD
- Adaptable according to the client’s needs
- Price on request
- No prerequisites are required to take this course
- A certificate of completion will be issued to beneficiaries at the end of the training
Our training courses are accessible to people with disabilities. We will offer you adaptation solutions (for example: training materials, training pace, educational support, etc.) and adjustments according to your needs.
Do your teams need training in analytical method validation that meets your theoretical and practical requirements?
Training in method validation and analytical validation
Why take analytical validation training?
In the pharmaceutical and medical device sectors, analytical method validation is a key lever for ensuring the reliability of results and product compliance with quality requirements. The chemical analysis methods used must be rigorously validated to ensure the accuracy, reproducibility, and robustness of the data generated.
Beyond simply applying validation parameters (accuracy, precision, linearity, specificity, etc.), regulatory authorities — such as ANSM, EMA, or the FDA — expect manufacturers to be able to justify their methodological choices.
This requires a thorough understanding of analytical criteria, their relevance to the method’s intended use, and how they are integrated into a documented and defensible quality approach during inspections.
Analytical validation training helps laboratory, QA, or regulatory teams better master the requirements, secure their analytical processes, and build an autonomous, compliant validation strategy.
FILAB laboratory analytical validation training
Have you just recruited new talent to your laboratory? Are the competent person or persons no longer part of your teams? Do you want to further develop your expertise in analytical method validation?
FILAB laboratory offers analytical validation training, providing you with our expertise in method validation and support in interpreting the results.
Tailor-made training
This analytical validation training is fully tailor-made. It is adapted to your industry, your products, your analytical methods, and your regulatory requirements.
In the pharmaceutical industry, it incorporates ICH Q2(R2) standards, EMA or FDA requirements, and covers cases such as HPLC validation for assay of an active ingredient or impurity testing.
For medical device manufacturers, it takes into account ISO 13485, ISO 17025, and applies for example to the validation of a cleanliness test, a residue assay method, or a material control.
You identify the essential analytical parameters (precision, accuracy, specificity, LOQ, measurement uncertainties). You learn how to build a structured validation protocol, carry out the tests, process the data, and compile a compliant and defensible file for audits.
Each session is led by technical experts. The examples, exercises, and materials are adapted to your methods and your industrial environment. A practical training course, immediately applicable in the laboratory.
FILAB, approved training organization and accredited laboratory
our expertise in analytical validation training
To register for the training or to obtain a quote, please contact us directly by email or phone.
The training will start within 3 months from the acceptance of the agreement.
Why choose FILAB for any training in analytical chemistry or materials?
The FILAB laboratory is QUALIOPI certified for its training activities.
Thanks to this certification, the training courses we provide may be eligible for funding requests from OPCOs.
Analytical training is essential for professionals seeking to master analysis and characterization techniques; indeed, it covers a wide range of techniques intended for the analysis and characterization of substances, materials, or products in various industrial sectors.
Our analytical training programs are designed to equip participants with the skills needed to excel in their field, combining rigorous theory with practical applications. Discover how our analytical training can transform your skill set within your company.
There are several reasons behind the growing number of training requests received by FILAB:
Tailor-made technical training: most of the training courses offered by many training organizations are standard, not tailor-made, and do not address your technical issues
Highly qualified people: our trainers are laboratory professionals, PhDs or specialized engineers
Industry knowledge: FILAB has been providing training to its clients for over 10 years, whatever the industry sector
A unique profile with dual expertise in Chemistry and Materials
A human-scale organization, which allows us to be more responsive and more flexible
FAQ
Because it ensures the reliability and traceability of analytical results, essential elements for demonstrating product compliance with regulatory authority requirements (FDA, EMA, ANSM…). A non-validated method can jeopardize an entire batch release, a regulatory submission, or an industrial transfer.
The main standards include the ICH Q2(R2) guidelines for medicines, ISO/IEC 17025 for laboratories, as well as the specific requirements of pharmacopoeias (USP, Ph. Eur.). For medical devices, the requirements of ISO 13485 and the IMDRF guidelines may also apply.
This training is aimed at analytical laboratory teams, Quality Assurance (QA) managers, regulatory teams, as well as analytical development project managers. Anyone involved in drafting, implementing, or interpreting an analytical validation is concerned.
The training covers in detail the parameters required for validating an analytical method: accuracy, precision (repeatability/reproducibility), specificity, linearity, range, limit of detection, limit of quantification, robustness, stability, etc., as well as their statistical interpretation.
It enables teams to justify their methodological choices in a well-argued way, build clear and compliant protocols, and confidently answer auditors’ questions about the validity of results. A well-documented and well-understood validation is a strategic asset during regulatory inspections.
