Monitoring and Trending in Quality Control and Production - Online Training Recording

Monitoring and Trending in Quality Control and Production - Online Training Recording

Costs

ECA-Member*: EUR 590,--
Regular Fee*: EUR 690,--
EU/GMP Inspectorates*: EUR 590,--
APIC Member Discount*: EUR 640,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

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

Speakers

Dr Joachim Ermer, Ermer Quality Consulting, Germany

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
OOT in Stability Investigations
  • Regulatory requirements (EU-GMP-Guide)
  • Identification of stability OOT by means of
    • Prediction intervals
    • Regression control Charts
    • Slope control charts
    • Time-point approach
 
Recording from 15 June 2022
Duration of Recording: 2,5 h
 

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