Validation of Analytical Test Procedures & Measurement Uncertainty

14-16 October 2025, Vienna, Austria

Course No. 21897

header-image

Speakers

Trevor Coomber

Trevor Coomber

Pharmaceutical Development Consultant

Dr. Xaver Schratt

Dr. Xaver Schratt

GBA Pharma

Dr. Christopher Burgess

Dr. Christopher Burgess

Burgess Analytical Consultancy

Objectives

The objectives of this Education Course are
  • to offer practical solutions for determining the validation characteristics ƒ
  • to learn how to deal with measurement uncertainty and to understand its impact on analytical methods validationƒ
  • to understand the qualification of laboratory equipment as a precondition of reliable analytical testingƒ
  • to discuss the scope of qualification & validation necessary
  • to obtain approval by the Registration Authorities (EMA, FDA, MHRA, etc.)ƒ
  • 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
  • to 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.

Background

The ICH guideline Q2 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 regulatory approval, the qualification of all critical laboratory equipment must be performed and documented ensuring “fitness for purpose”. 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.

Date & Venue

Date
Tuesday, 14 October 2025, 09.00 – 17.00 h
(Registration and coffee 8.30 – 09.00 h)
Wednesday, 15 October 2025, 8.30 – 17.30 h
Thursday, 16 October 2025, 8.30 – 16.30 h

Venue
Austria Trend
Parkhotel Schönbrunn
Hietzinger Hauptstr. 10-14
1130 Wien, Austria
Phone: +43 (1) 878 08 0
Fax: +43 (1) 878 04 630
E-Mail: parkhotel.schoenbrunn@austria-trend.at

Programme

Validation of Analytical Test Procedures & Measurement Uncertainty

Seminar Programme as PDF

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
  • Qualification, Calibration & Validation
  • Measurement uncertainty
  • Propagation of Errors
  • Measurement uncertainty of a CRM
  • Detection and quantitation limits
  • Noise & drift
  • Statistical aspects
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
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
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.

stop

This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more

ECA-Member*: € 2090,-
Non ECA Member*: € 2290,-
EU/GMP Inspectorates*: € 1145,-
APIC Member Discount*: € 2190,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available
icon
Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
Live Online Training - GMP Auditor Practice, October 2024

"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
Live Online Training - GMP Auditor Practice, October 2024

"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023