Statistical Process Control in the Pharmaceutical Industry - Live Online Training
A Tool to get Process Understanding
5/6 February 2026
Course No. 22184
Target Group
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.
Objectives
The new process validation life cycle is now split up into 3 stages:
Process Design
Process Qualification
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.
Background
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.
Programme
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
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: SPC as Tool for Continued Process Verification
Continued Process Verification: Requirements
Case Study Sanofi-Aventis
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.
Further Information
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.
Conference language The official conference language will be English.
Fees (per delegate, plus VAT) ECA Members € 1,890 APIC Members € 1,990 Non-ECA Members € 2,090 EU GMP Inspectorates € 1,045 The fee is payable in advance after receipt of invoice.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
GMP/GDP Certification Scheme Building on your education the ECA GMP/GDP certification programmes provide you with the appropriate supplement to acquire this qualification. Simply choose any three Courses within the programme according to your professional interest. Your certificate is then valid for two years. To renew it, you can pick any training from the ECA courses and conferences list within that two-years period – allowing you to broaden your knowledge in GMP and GDP compliance.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
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