Pre-course session Statistical Process Evaluation and Reporting

Pre-course session Statistical Process Evaluation and Reporting

Vienna, Austria

Course No 15891


Costs

Non-ECA Members: EUR 990,--
ECA Members: EUR 890,--
EU GMP Inspectorates: EUR 495,--
APIC members: EUR 945,--
QP Association Members: EUR 890,--

(All prices excl. VAT)

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

Speakers

Prof Edwin van den Heuvel, University of Technology Eindhoven

Objectives

This pre-course session will provide you recommendations, tools and examples to apply statistical principles in your day-to-day business as well as to meet future challenges.

Working with statistical simulation tools, you will gain understanding of the consequences of appropriate and inappropriate performance parameters and a sound evaluation of data.

Target Group

Managers, supervisors and all other staff members in the pharmaceutical and API industry who are involved in preparing and compiling Quality Reviews and Metrics.

Programme

The Application of statistical Tools in Data Review
Introduction

  • Ongoing/data collection and management
  • Interpretation, comparison and presentation of data
  • Describing process capability and performance
  • Control Charts; what is a trend and how to deal with it?
  • Quality Metrics
  • Documenting the outcomes; are we in control?
Quality Review Summary Report
  • Descriptive Statistics
  • Outlier detection
  • Normality testing
Quality Review Performance
  • Control Charts
  • Capability Indices

The Session includes a Workshop with Minitab Software: What are the Data telling us?
A case study on analysing and interpreting process performance data.

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