Validation of Analytical Test Procedures and Measurement Uncertainty

Validation of Analytical Test Procedures and Measurement Uncertainty

Prague, Czech Republic

Course No 15172


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Christopher Burgess, Burgess Analytical Consultancy, UK
Trevor Coomber, Pharmaceutical Development Consultant, UK
Dr Xaver Schratt, LPU Labor für Pharma- und Umweltanalytik GmbH, Germany

Objectives

The objectives of this Education Course are
to offer practical solutions for determining the validation characteristics
to learn how to deal with measurement uncertainty and to understand its impact on analytical methods validation
to discuss the scope of validation necessary to obtain approval by the Registration Authorities (EMA, FDA, MHRA, etc.)
to become familiar with the statistical parameters to be applied
to understand the qualification of laboratory equipment as a precondition of reliable analytical testing
to outline the documentation (SOPs, Validation Protocols and Reports, etc.) which you should have in your lab.
In order to improve the understanding and practical application of the contents of the lectures, workshops will be part of the training course.

Background

Guideline Q2(R1) lists all characteristics to be considered during validation and describes the method of determining the various validation characteristics. Reliable analytical results do not only require validated test procedures but also the use of analytical equipment qualified for its intended purpose. In order to obtain the FDA investigator‘s approval, the qualification of all critical laboratory equipment should be performed in standard IQ/OQ/PQ format. Furthermore, measurement uncertainty is of key importance in analytical instruments qualification as well as in analytical methods validation and transfer. Therefore it is absolutely essential that measurement uncertainty is well understood by everybody who is responsible for generating and evaluating analytical results in GMP controlled laboratories.

Target Group

This interactive Education Course will be of particular interest to Laboratory Managers, Supervisors and Analysts in pharmaceutical quality control departments who have responsibility for the validation of analytical test procedures. Furthermore, this Course is designed for personnel from Quality Assurance, Regulatory Affairs and Contract Laboratories.

Free brochure “Validation of Analytical Test Procedures”

Each participant gets a brochure containing over 200 pages of examples and validation protocols on analytical methods validation for free.

Programme

Validation in Context
Components of data quality
Integrated Approach to Qualification and Validation
Conclusion

Basics of Measurement Uncertainty
Why is measurement uncertainty important?
Relationship between uncertainty and confidence
Uncertainty of measurement
What is a measurand
Error sources in analysis and testing

Analytical Instrument Qualification
Guidance
Validation Master Plan
Definition of DQ, IQ, OQ and PQ
Examples of protocols and documents
Change Control
Risk assessment

Measurement Uncertainty in Calibration and Qualification of Analytical Instruments
Qualification, Calibration & Validation
Measurement uncertainty
Propagation of Errors
Measurement uncertainty of a CRM
Detection and quantitation limits
Noise & drift
Statistical aspects

New Developments in Instrument Qualification - The USP Proposals
Statistical Aspects of Analytical Methods Validation
The use (and misuse?) of statistics to support validation data
Basic theory of the common statistical techniques
Merits, pitfalls and underlying assumptions of particular tests
The meaning behind
Standard deviation - F-test - t-test
ANOVA - Correlation Coefficient
Linear regression
Exploration of more sophisticated statistical techniques such as interval hypothesis testing and experimental design

Practical Determination of: Robustness Leading to System Suitability Tests
Method development cycle
Analytical process capability
Selecting factors and levels
HPLC experimental design example
Impact on system suitability tests

Method Validation During the Development Lifeycle
Product Development Life Cycle
Sources of Guidance
Screening and Early Safety Studies
Phase 1 Volunteer Studies
Phase 2 Clinical trials
Towards MAA/NDA

Validation for MAA/NDA Planning and Execution
Analytical validation according to USP
FDA Guidances for method validation

Validation for MAA/NDA Documentation
Validation report
ransfer protocol/report
Validation documentation for registration
Validation software
Other Sources of Guidance

Error budgets and reportable values
What is a reportable value?
OOS, OOE & OOT
Method performance and process capability
ICH precision approach
Measurement Uncertainty approach combined sources of variation

Transfer of Analytical Test Procedures
Statistical Tests
Analytical significance vs statistical significance
Acceptance criteria setting
Interval hypotheses

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