Validation of Analytical Test Procedures & Measurement Uncertainty
13-15 October 2026, Barcelona, Spain
Course No. 22245
Speakers
Trevor Coomber
Pharmaceutical Development Consultant
Dr. Xaver Schratt
GBA Pharma
Dr Christopher Burgess
Burgess Consultancy
Including Bioanalytical Procedure Performance Qualification, Measurement Uncertainty & ATP, and the latest USP & ICH developments
Target Group
Laboratory Managers, Supervisors and Analysts in Pharmaceutical quality control departments who have responsibility for the validation of analytical test procedures
Personnel from Quality Assurance, Regulatory Affairs and Contract Laboratories
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 understand the qualification of laboratory equipment as a precondition of reliable analytical testing
to discuss the scope of qualification & validation necessary to obtain approval by the Registration Authorities (EMA, FDA, MHRA, etc.)
to become familiar with the statistical parameters to be applied
to outline the documentation (SOPs, Validation Protocols and Reports, etc.) which you should have in your lab.
Provide an outline of the new USP & ICH developments of procedure validation
In order to improve the understanding and practical application of the contents of the lectures, workshops will be part of the training Course.
Programme
Validation in Context
Practical components of data quality
Assessment of data Quality
Analytical Procedure Life Cycle Management; the future direction
Course road map
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
USP <1058> Guidance
USP revision process and GAMP
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 & Reportable Values
Qualification, Calibration & Validation
Measurement uncertainty
Propagation of Errors
Measurement uncertainty of a CRM
Detection and quantitation Limits
Noise & drift
Statistical aspects
What is a reportable value?
Method performance and process capability
Analytical Procedure Life Cycle Management; the Future Direction
Validation; the changing regulatory climate
FDA Process Validation Paradigm shift
Analytical Procedure Life Cycle Management
Data governance in a regulated laboratory
ICH Q12
USP <1220>
ECA APLM guideline
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 - Linear regression; Correlation Coefficient & Coefficient of Determination
Exploration of more sophisticated statistical techniques such as interval hypothesis testing and experimental design
Robustness and Ruggedness: the Pathway 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 Life Cycle
Product Development Life Cycle
Sources of Guidance
ICH Q14 Concept paper
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
Transfer protocol/report
Validation documentation for registration
Validation software
Other Sources of Guidance
Performance Qualification of Bioanalytical Procedures; Similarities and Differences
What makes Bioassays special?
Key aspects of USP <1030> and the biological assays Triage
ICH Q2(R2) and USP <1033>
Application of performance qualification acceptance criteria
Transfer of Analytical Test Procedures
Statistical Tests
Analytical significance vs statistical significance
Acceptance criteria Setting
Interval hypotheses
Comparison of the APLM and Current ICH & USP Approaches
Traditional approach to analytical method (procedure) validation, verification and transfer - ICH Q2 - USP <1225> & <1226> [& <1224>]
FDA process validation guidelines 2011
USP initiatives: Application to analytical processes
Proposed General Chapter <1220>
Statistical toolbox for<1225>; General Chapter <1210>
New ECA AQC Guideline
Analytical Procedure Life Cycle Management
New ICH initiatives
Workshops During the Course, 4 workshops will be conducted in order to deepen the content of the lectures and to discuss practical aspects in detail. Workshops will be offered on the following topics:
Analytical Instrument Qualification The participants will debate the impact of USP proposals in a practical context Validation Plan The participants will work on testing schedules for the relevant validation parameters. Validation Documents Critique The participants will work, in detail, on a typical case study proposing a suitable program of work for a validation dossier. Method Transfer The participants will discuss practical details of an Analytical Methods Transfer.
Further Information
Venue Barceló Sants Hotel Plaça dels Països Catalans, s/n 08014 Barcelona Spain +34 (93) 503 53 00 sants@barcelo.com
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT) Non-ECA Members € 2,490 ECA Members € 2,290 APIC Members € 2,390 EU GMP Inspectorates € 1,245 The conference fee is payable in advance after receipt of invoice and includes social event on the first day, lunch on three days and all refreshments. VAT is reclaimable.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
