Monitoring and Trending in Quality Control and Production - Online Training Recording
Course No. 19456A
Speakers
Dr. Joachim Ermer
Ermer Quality Consulting
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). 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 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.
Please be aware: The recording does not include the Q & A sessions.
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
„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
Testimonials