Live Online Training:Pre-Course Session: Statistical Process Evaluation and Reporting

Live Online Training:Pre-Course Session: Statistical Process Evaluation and Reporting

Course No 19466

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

All times mentioned are CET.

Costs

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

(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.

Technical Requirements

For our online training, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

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
  • Case study on analysing and interpreting process performance data

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