Course No 16883
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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.
Note: The number of participants is limited.
Practical trainings give the delegates the information about how control charts are used to optimise processes.
The delegates will set up a control chart (initial study). This chart will then be used to monitor a process (control to standard) and to detect changes and to analyse potential causes.
An additional workshop shows Dos and Don’ts and how to get the commitment of superiors and other teammates.
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