Statistics in Pharma - life cycle of validation according to Annex 15
Statistics in Pharma - life cycle of validation according to Annex 15
Trainer:
Dr. Marek Skowronek, StatSoft Polska
The scope of the training covers the guidance in Annex 15 on the life cycle approach to validation, with an emphasis on the use of statistical methods for data analysis. The course combines practical knowledge on topics specific to the pharmaceutical industry with knowledge of data analysis methods presented on the basis of data from this industry. Individual statistical questions are first discussed theoretically and then developed in the form of exercises.
For whom?
For anyone responsible for process validation. We invite you if you do not yet know anything about data analysis and statistics for technological process validation. Likewise, if you would like to refresh and deepen your knowledge. Even if you already know the statistics, but need a tool with which you can carry out your analyses quickly and easily. This training is the basis on which you can expand your knowledge and skills in data analysis.
Your advantages:
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- You will get to know or systematize the basic concepts of statistical data analysis,
- You will go through the phases of technological process validation yourself,
- You will learn about numerical and graphical methods of data analysis and traps that await the process engineer,
- You will learn about selected topics of process stability and capability assessment,
- You will receive practical tips on how to avoid errors in data analysis and interpretation,
- You will acquire the basis for developing analytical skills and
- You will learn how to plan the statistical control of the technological process
Training content:
1. Introduction
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- What is the modern definition of quality?
- What are the basic requirements for implementing the validation life cycle?
- What are the conditions and criteria for the transition between validation life cycle phases?
- What product/process parameters need to be included in the statistical process control program?
- What is the typical test plan for process validation / ongoing process verification?
- How do I deal with difficult cases of unstable and / or incapable processes?
- How are OOT results recognized during ongoing process verification?
- How to implement the principle of continuous improvement based on statistical analysis results?
2. Population and sampling
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- What is a population / random sample?
- What are the characteristics of the general population / random sample?
- What are the sampling errors and how can they be controlled?
- What types of samples are there?
- Exercises and examples of sampling.
3. Statistical description
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- What is the average value of the data set?
- What is the dispersion of the data set?
- Whether the distribution is unimodal or multimodal?
- Whether the distribution is symmetrical or asymmetrical?
- Are there outliers / extreme values?
- What is the confidence / prediction interval?
- Exercises and examples for describing statistical data
4. Analysis of process stability
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- What is the purpose of process stability analysis?
- What is the difference between special and common causes?
- What is the difference between the first type defect and the second type defect?
- Which control charts should be used for process stability analysis
- What are the basic principles for using control charts?
What are the process stability criteria? - When and which additional configuration tests should be used?
- How are control limits set for ongoing process monitoring?
- In which cases should the set control limits be changed?
- When is a change to the limits justified?
- What if the points are outside the control limits?
- What if the data has a different distribution than normal?
- Exercises and examples for process stability analysis
5. Analysis of process capability
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- What is the purpose of process capability analysis?
What are the basic principles of process capability analysis? - How are basic process capability indicators determined?
- What is the difference between Cp / Cpk and Pp / Pk indicators?
- What requirements must be met for capacity indicators to be reliable?
- What mistakes can be made when determining process capability indicators?
- When can a process be considered predictable and fulfill the acceptance criteria?
- How can a process be categorized based on statistical analysis results?
- What measures should be taken for unstable and/or incapable processes?
- Exercises and examples of process capability analysis.
- What is the purpose of process capability analysis?
Presentation:
The lecture will be held in English. The training documentation will all be in English. All participants will receive a printed version of the documentation for personal use only.
Prerequisites:
Computer skills in a Windows environment
Location
- Online: These training sessions offer maximum flexibility without the need to travel. All participants work on their own PCs. We recommend using two monitors for this purpose.
- Hamburg: With our training center in Hamburg, we provide a comfortable place for successful learning.
We offer all our training sessions in both German and English languages.
Duration: 2 days | Price: Total up to 6 participants: starting from EUR 3.900,-
Sign up yourself and your team directly for this training:
After the registration request, the trainer will contact you directly and arrange the date personally.
Do you have questions about the content, the implementation or would you like an individually customized training? Contact us and speak directly with the responsible trainers without obligation. We are sure that we can help you!