„„ SPC - a tool regarding the new FDA

Validation Guidance requirement on

process understanding

Statistical Process Control

A key tool for process understanding in the process
validation life cycle

A key tool for continuous validation

20 - 21 March 2014, Heidelberg, Germany

SPEAKERS: LEARNING OBJECTIVES:

Dr Sven Wedemeyer „„ Six Sigma
Merck KGaA, Germany
„„ Basic Statistic
Klemens Wendl „„ Process Improvement
Baxter AG, Austria
„„ Process Capability
„„ Case Study “SPC and Trending of
Microbiological Data”
„„ 1 Workshop
„„ 2 Exercises

This education course is recognised for the ECA GMP Certification Programme „Certified Validation Manager“. Please find details at www.gmp-certification.eu
Statistical Process Control
20 - 21 March 2014, Heidelberg, Germany

Objectives Moderator

The new process Validation life cycle is now split up into Dr Sven Wedemeyer, Merck KGaA
3 stages:

1. Process Design Workshop/Exercises

2. Process Qualification
3. Continued Process Verification Practical trainings give the delegates the information
about how control charts are used to optimise processes.
The new “catchword” is process understanding. Trends
should be evaluated in the Stage 3. The delegates will set up a control chart (initial study).
This chart will then be used to monitor a process (control
One element to show process understanding and to to standard) and to detect changes and to analyse poten-
monitor trends can be Statistical Process Control. tial causes.

On the one hand the seminar will explain the theory of An additional workshop shows Dos and Don’ts and how
control charts e.g. how to calculate and read them. On to get the commitment of superiors and other team-
the other hand the seminar will explore how to practi- mates.
cally 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 exer- Programme
cises supports a hands-on approach to manage and use
Control Charts in different environments, like validation Six Sigma Definitions
and process improvement. „„ A short introduction to Six Sigma
„„ Six Sigma Terms
Examples and case studies from the experience of the
speakers will give evidence of the success and possibili- Objectives of Statistical Process Control
ties the use of Control Charts adds to your enterprise. „„ Create visibility of process performance
Additionally, there is a view on the software for SPC and „„ Increase process knowledge
its GMP relevance. „„ Show process stability
„„ Prove process capability
„„ Support the continuous improvement process
Background
Some mandatory Basic Statistics
With the FDA Guidance on Process Validation of January „„ Mean Value, Median, Range
2011 the FDA gives a new interpretation of validation. Not „„ Standard Deviation
more than 3 validation batches are the evidence that a „„ Normal Distribution
process is valid. The FDA now expects a validation life „„ Histogram and Time Series Plot
cycle with continued process verification throughout the
commercial phase. Also the EMA stated in a Question The two Types of Variability
and Answer paper, that they focus on continuous valida- „„ Common cause variability
tion too. Both authorities mention that a process is in sta- „„ Special cause variability
tistical control and capable. One element to show this is
Statistical Process Control (SPC) as mentioned by the Control Charts
FDA. „„ Types of control charts
„„ Design a control chart
Also in the ICH Q9 document “Quality Risk Manage- „„ Setting up control charts in Minitab®
ment” control charts and process capability are men- „„ Control limits and specification limits
tioned as statistical possibilities within risk assessments. „„ Why is 3s taken as limit?
„„ Changing control limits

Target Audience Reading Control Charts to improve the Process

„„ Statistical rules
This course is directed to staff who is involved in process „„ Identifying patterns
understanding and optimization (e.g. process owners, „„ Performance windows
validation managers, etc.) in R&D, production and qual- „„ General rules
ity control. It also addresses quality assurance staff.

Note: The number of participants is limited.

Deploying and managing SPC - Connecting SPC to Speakers
Continuous Improvement
„„ Deployment Top-Down versus Bottom-Up Dr Sven Wedemeyer
„„ Root cause analysis Merck KGaA, Darmstadt, Germany
„„ Paper based versus electronic control charts Dr Wedemeyer studied Process Engineering
„„ Management system / cycle at the TU Clausthal and received his PhD
from the same university. He joined Merck
Reasons to implement Control Charts in 1999 and headed different position (e.g
„„ Link to quality control Assistant Plant Manger in the solids manufacturing
„„ Link to quality assurance department). Dr Wedemeyer started his Black Belt
„„ Benefits from SPC education in 2005. Since that time he is performing Six
Sigma projects in manufacturing and supply chain. He is
Measurement System Analysis and SPC member of the Operational Excellence team leading the
„„ Using control charts to do a MSA transformation program in Technical Operations.
„„ Accuracy of data
„„ Triangle of Variability Klemens Wendl
Baxter AG, Vienna , Austria
Klemens Wendl has been with Baxter since
Exercise 1 1999. Klemens has worked in various posi-
Control chart tions at Baxter e.g. Microbiology, Quality
Setting up a Control Chart and control a process to Assurance, Supervisor Sterility Assurance:
standard manually In May 2008 he became Global Project Manager, and in
this position he is responsible for the global implementa-
tion and standardisation of Statistical Process Control.
Workshop
Implementation of the use of a Control Chart in the
local environment Social Event

„„ What are the Dos and Don’ts? On 20 March 2014 you are cordially invited to a social
„„ How do I create commitment in senior management event.
and my team?
This is an excellent opportunity to share your experienc-
es with colleagues from other companies in a relaxed at-
Exercise 2 mosphere.
Control Chart
Detecting changes and analysing potential causes

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
„„ Computerized systems as basis
„„ General use of control charts for microbiological data
(Environmental monitoring, personnel monitoring,
water monitoring, product bioburden)
„„ Distribution of microbiological data
„„ Minimum number of data to establish control limits
„„ Specify „trending rules“ for microbiological data
„„ Frequency of Trending
„„ General approach on encountering a negative trend
„„ Case study
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