Monitoring and Trending in Quality Control and Production - Live Online Training
Tuesday, 8 November 2022 14.00 - 17.30 h
Course No. 19458
Speakers
Dr Joachim Ermer
Ermer Quality Consulting
All times mentioned are CET.
Objectives
This Live Online Training provides fundamentals with respect to
the statistical distribution of data
the selection, generation, and use of statistical control charts
Recommendations are given
for identification of results outside of expectation (OOE) and outside of trends (OOT)
for analysis of trends
The seminar covers the monitoring of product and process data, as well as analytical performance data and stability results.
Background
In order to ensure quality, safety, and efficacy of pharmaceuticals, an appropriate control of the capability of the manufacturing process (EU GMP Guide Part 1, Annex 15), as well as of the analytical performance (EU GMP Guide Part 1, Chapter 6, Quality Control (6.16), FDA Method Validation Guidance) is important, during the whole lifecycle. A regular evaluation is expected, e.g. as Annual Quality Review (FDA, 21CFR 211.180(e)) or Product Quality Review (EU GMP Guide 1.10). The importance of a monitoring of analytical performance to identify proactively failures and adverse trends is discussed in the FDA-Guidance „Analytical Procedures and Methods Validation for Drugs and Biologics“ (2015) and also in the draft of the new ICH guideline Q14 „Analytical procedure development“.
Unlike the rules established for investigation of results outside of specification (OOS), no detailed advice is provided by the authorities in case of results outside of expectation or outside of trends. However, this opens up the flexibility to establish suitable monitoring and trending programs of own choice.
Target Group
This Training is aimed at executives and employees from quality control and analytical development as well as quality assurance and production responsible for evaluation and monitoring of analytical results.
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings 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.
Programme
„Normal“ Distribution of Data
Regulatory expectations to the quality of product and analytical results
Error types: random and systematic Errors
Distribution of data
Capability Indices
Outlier Tests
Trend tests
Appropriate consideration of variability contributions (manufacturing and analytics, precision levels)
Statistical Control Charts and OOE Limits
Statistical basics and out-of-control rules
Control chart types and their appropriate selection (individuals and means, moving range, CUSUM, range, standard deviation control charts)
Software
Practice check: Always statistics?
Statistical and empirical OOE limits
Suitable parameter to monitor analytical performance
Workshop Control Charts
OOT in Stability Investigations
Regulatory requirements (EU-GMP-Guide)
Identification of stability OOT by means of
Prediction intervals
Regression control charts
Time-point approach
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Testimonials
Seminar Programme as PDF