Validation of Analytical Test Procedures & Measurement Uncertainty - Online Training Recording

Costs

*ECA-Member:**	EUR 1790,--
*Regular Fee:**	EUR 1990,--
*EU/GMP Inspectorates:**	EUR 995,--
*APIC Member Discount:**	EUR 1890,--

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

Registration

* also payable by credit card

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

Speakers

Dr Christopher Burgess, Burgess Analytical Consultancy, UK
Trevor J. Coomber, Pharmaceutical Development Consultant, UK
Dr Xaver Schratt, GBA Pharma, Germany

Objectives

The objectives of this Live Online Training 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.
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 current ICH 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 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. In addition there are major revisions planned for both ICH Q2 and a new Q14 on Analytical Procedure Development.

Target Group

This Live Online Training 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.

Technical Details

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:

When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Training Course Documentation and Certificate:

The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

Programme

Welcome and Introduction

Validation in Context

Practical components of data quality
Assessment of data quality
Analytical Procedure Lifecycle 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 Lifecycle Management; the Future Direction

Validation; the changing regulatory climate
FDA Process Validation Paradigm shift
Analytical Procedure Lifecycle 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 Lifeycle

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 ICH Q2(R1)
FDA Guidances and USP proposals 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(R1)
- 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 Lifecycle 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
Validation Plan
Validation Documents Critique
Method Transfer

Recording from 19 - 21 October 2021
Duration of the recording: about 11 h

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