Process Understanding - Live Online Training

6/7 February 2025

Seminar-Nr. 21653


Dr. Sven Wedemeyer

Dr. Sven Wedemeyer


Dr Ingolf Stückrath

Dr Ingolf Stückrath

Sanofi-Aventis Deutschland

Dr. Björn Wiese

Dr. Björn Wiese

Janssen Cilag

All times mentioned are CET.


The new process validation life cycle is now split up into 3 stages:
1.  Process Design
2.  Process Qualification
3.  Continued Process Verification
The new “catchword” is process understanding. Trends should be evaluated in the Stage 3.
One element to show process understanding and to monitor trends can be Statistical Process Control.
On the one hand the seminar will explain the theory of control charts e.g. how to calculate and read them. On the other hand the seminar will explore how to practically apply Control Charts, e.g. implementing control charts in production or QC and setting up a good review process. This balance of class room sessions and exercises supports a hands-on approach to manage and use Control Charts in different environments, like validation and process improvement.
Examples and case studies from the experience of the speakers will give evidence of the success and possibilities the use of Control Charts adds to your enterprise. Additionally, there is a view on the software for SPC and its GMP relevance.


With the new FDA Guidance on Process Validation of January 2011 the FDA gives a new interpretation of validation. Not more than 3 validation batches are the evidence that a process is valid. The FDA now expects a  validation life cycle with Continued Process Verification throughout the commercial phase. This is the same in the revised Annex 15 in the EU. Also the EMA stated in a Question and Answer paper, that they focus on continuous validation too. Both authorities mention that a process is in statistical control and capable. One element to show this is Statistical Process Control (SPC) as mentioned by the FDA.
Also in the ICH Q9 document “Quality Risk Management” control charts and process capability are mentioned as statistical possibilities within risk assessments.


This course is directed to staff who is involved in process understanding and optimization (e.g. process owners, validation managers, etc.) in R&D, production and quality control. It also addresses quality assurance staff.

Technical Requirements

We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.


Process Understanding - Live Online Training

Gesamtes Programm als PDF herunterladen

Six Sigma Definitions
  • A short introduction to Six Sigma
  • Six Sigma Terms
Objectives of Statistical Process Control
  • Create visibility of process performance
  • Increase process knowledge
  • Show process stability
  • Prove process capability
  • Support the continuous improvement process
Some Mandatory Basic Statistics
  • Mean Value, Median, Range
  • Standard Deviation
  • Normal Distribution
  • Histogram and Time Series Plot
The Two Types of Variability
  • Common cause variability
  • Special cause variability
Control Charts
  • Types of control charts
  • Design a control chart
  • Setting up control charts in Minitab®
  • Control limits and specification limits
  • Why is 3s taken as limit?
  • Changing control limits
Reading Control Charts to improve the Process
  • Statistical rules
  • Identifying patterns
  • Performance windows
  • General rules
Deploying and Managing SPC - Connecting SPC to Continuous Improvement
  • Deployment Top-Down versus Bottom-Up
  • Root cause analysis
  • Paper based versus electronic control charts
  • Management system / cycle
Reasons to Implement Control Charts
  • Link to quality control
  • Link to quality assurance
  • Benefits from SPC
Measurement System Analysis and SPC
  • Using control charts to do a MSA
  • Accuracy of data
  • Triangle of Variability
SPC as Tool for Continued Process Verification
  • Continued Process Verification: Requirements
  • Case Study Sanofi-Aventis
Process Capability – What is the Risk of Failure of My Process?
  • Cp, Cpk versus Pp, Ppk
  • Long term versus short term capability
  • Process robustness
Case Study Control Charts and Trending of Microbiological Data
  • Trending Monitoring Data as Part of the Facility Control Concept
  • Smart Setting of Alert- and Action levels
  • Definition of Adverse Trends
  • Periodic Data Review
  • Designing a Reduced EM Program
Q & A Sessions
Three  Q &A sessions (two on day 1 and one on day 2) ensure interaction and that your questions are answered.

ECA-Member*: € 1690,-
Non ECA Member*: € 1890,-
EU/GMP Inspectorates*: € 945,-
APIC Member Discount*: € 1790,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
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Teilnehmerstimmen - das sagen andere über unsere Seminare:

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023


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