Dr Christopher Burgess
Burgess Analytical Consultancy
Referent:innen
Dr Joachim Ermer
Ermer Quality Consulting
Zielgruppe
This Live Online Training is designed for analytical laboratory managers and their colleagues charged with the day to day management and evaluation of laboratory data throughout the lifecycle, i.e. in method development, validation, transfer, specification setting, batch release and stability, continuous performance verification and change control.
QA, manufacturing and regulatory affairs professionals will benefit from participation by gaining a clear understanding of the statistical fundamentals which are important to implement scientifically sound and pragmatic tools to conform to GMP and regulatory requirements for example Product Quality Review.
QA, manufacturing and regulatory affairs professionals will benefit from participation by gaining a clear understanding of the statistical fundamentals which are important to implement scientifically sound and pragmatic tools to conform to GMP and regulatory requirements for example Product Quality Review.
Zielsetzung
This Live Online Training will provide the participants with recommendations, tools and examples to apply scientifically and pragmatically sound statistical principles to their day-to-day business as well as to meet future challenges.
A brief discussion of supporting software tools (e.g. Excel, Minitab, JMP) to facilitate the generation of statistical information in a consistent manner will be undertaken.
One of the main features of this course is the balance of presentations and more than four hours of practical exercise workshops which will allow participants to gain ‘hands on’ practical experience in applying the statistical methods described. By means of statistical simulation tools, the participants will gain intuitive understanding of the consequences of appropriate and inappropriate performance parameters, for example the relationship between precision and OOS results.
A brief discussion of supporting software tools (e.g. Excel, Minitab, JMP) to facilitate the generation of statistical information in a consistent manner will be undertaken.
One of the main features of this course is the balance of presentations and more than four hours of practical exercise workshops which will allow participants to gain ‘hands on’ practical experience in applying the statistical methods described. By means of statistical simulation tools, the participants will gain intuitive understanding of the consequences of appropriate and inappropriate performance parameters, for example the relationship between precision and OOS results.
Background
Statistical calculations and tools are applied extensively in pharmaceutical analysis including
- Procedure development and validation
- Transfer of analytical procedures
- Setting or verification of specification Limits
- Data evaluation, comparison and trending
Consequently, a thorough understanding of statistical fundamentals is essential in order to be able to select parameters and test methods that are ‘fit for purpose’.
Programm
Analytical Procedure Lifecycle Management Overview
- Principles of APLM
- USP <1220>
- Risk based approach
- Target Measurement Uncertainty
- Decision rules
(Normal) Distribution of Data and its Parameters
- Data shape and its importance
- Characterisation of distributions (Location and Dispersion)
- Probability considerations; all measurements are subject to error
- Populations and samples
- Confidence intervals
- What is an outlier?
- Error of the error
Calculation and Evaluation of Precision Levels
- System precision, repeatability, intermediate precision, reproducibility
- ANOVA: Identification of relevant variance components from injection, measurement, sample preparation, intermediate conditions
- Total variability: precision of the reportable result and its optimisation
- Relationship between precision and probability of OOS results
- Practically relevant acceptance criteria for precision
WORKSHOP I: Understanding the Variability (Statistical Simulations)
- Scatter of results and risk of OOS
- Variability of standard deviations
- Number of data and reliability of calculated Standard deviations
WORKSHOP II: Optimisation of Variability
- Statistically based format of the reportable result (single or average)
- Number of determinations for various levels
Trending of Data
- Why trend?
- Evaluation; do we expect a trend or not?
- Statistical Process Control principles
- Types of Control charts and their application
- Application to stability testing
WORKSHOP III: Control Charts & Trending
- Interactive workshop based on supplied real data sets for Interpretation
- Use of Minitab for control charting
- Team working on evaluation and interpretation of trend data
Measurement Uncertainty without the Maths; Introduction to Monte Carlo Simulation
- Principles of Monte Carlo Simulation
- Understanding variance contributions and how they Combine
- Measurement uncertainty
- Application to analytical procedures
- Examples of unit and complete procedures using Companion by Minitab
Comparison of Data & Accuracy
- Significance (F- and t-test) and equivalence Tests
- Statistical significance and practical relevance
- Differences caused by random variability: observed and true bias
- Applications in transfer and cross-validation
WORKSHOP IV: Comparison of Data (Statistical Simulations)
- Significance and equivalence tests: impact of number of data and series
- Differences between means and variability
Calibration Models, Linear and non-Linear
- What is a calibration model?
- What is the difference between linear and non-linear models?
- The principle of least squares and why it is important
- Applying the principles to linear and non-linear models
WORKSHOP V: Linearity (Statistical Simulations)
- Regression range and evaluation of the intercept
- Extrapolation effects
Performance Requirements for Impurity Procedures
- Concentration dependence of precision (Horwitz relation)
- Detection and Quantitation Limits
Summary Workshop & Discussion: Appropriate Choice of Tests/Calculations
- Practical objectives and data sets are provided
- The participants will discuss and define appropriate tests and parameters to be calculated
- The participants are given the calculation results and are asked to make an Evaluation
- The defined tests and results are discussed in the audience
Weitere Informationen
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate, plus VAT)
ECA Members € 1,890.-
APIC Members € 1,990.-
Non-ECA Members € 2,090.-
EU GMP Inspectorates € 1,045.-
The conference fee is payable in advance after receipt of invoice.
ECA Members € 1,890.-
APIC Members € 1,990.-
Non-ECA Members € 2,090.-
EU GMP Inspectorates € 1,045.-
The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
The official conference language will be English.
Contacts
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 (0)6221 84 44 22, nicole.bach@concept-heidelberg.de
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 (0)6221 84 44 22, nicole.bach@concept-heidelberg.de
Datum & Uhrzeiten
Tue., 20 October 2026, 09.00 - 17.15 h
Wed., 21 October 2026, 09.00 - 17.15 h
All times mentioned are CEST.
Wed., 21 October 2026, 09.00 - 17.15 h
All times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager"
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E-Mail: info@concept-heidelberg.de
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