Pre-Course Session: Statistical Process Evaluation and Reporting

Pre-Course Session: Statistical Process Evaluation and Reporting

Hamburg, Germany

Course No 18912

This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager". Learn more.

 

Costs

ECA-Member*: EUR 890,--
Non ECA Member*: EUR 990,--
EU/GMP Inspectorates*: EUR 495,--
APIC Member Discount*: EUR 945,--
QP Member Discount*: EUR 890,--

(All prices excl. VAT)

* 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@gmp-compliance.org

Speakers

Dr Rainer Gnibl, GMP Inspector for EMA
Prof Edwin van den Heuvel, University of Technology Eindhoven
Dr Andreas König, Quality König
Dr Jens-Uwe Rengers, JeRo Consulting
Aline Zillig, Kite Pharma

Objectives

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

You will gain understanding of the consequences of appropriate and inappropriate performance parameters and a sound evaluation of data also by working with statistical simulation tools.

Target Group

This Education Course is designed for 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 a statistical Software to explain and understand: What are the Data telling us?

A case study on analysing and interpreting process Performance data.

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