Statistical methods in evaluation and monitoring of manufacturing environment

Participants will become familiar with the requirements and guidelines for environmental monitoring and methods for analysing data that can be used to assess trends, seasonality, outliers and setting of alarm and action limits. Individual topics will be initially discussed theoretically and then developed through exercises.

Who should attend?

• Anyone involved in analysing data collected during periodic evaluation of the environment: air, water and other media. We invite you if you still do not know anything about data analysis and statistics used in monitoring of the manufacturing environment. If you already know something, but need to structure your knowledge and move on to practice. Also if you are already familiar with statistics, but need a tool with which to perform your analyses quickly and easily. This course is the foundation on which you can further build your data analysis knowledge and skills

What will you learn?

• You learn or systematise the basic concepts of statistical data analysis
• You are familiar with numerical and graphical data analysis methods
• You will receive practical guidance on how to avoid errors in data analysis and interpretation
• You will gain a basis for developing your analytical skills
• You will learn how to plan statistical control of manufacturing environment parameters

Training programme:

1. Introduction
   • What are the basic GMP regulations for monitoring air, water and other media
   • Which plant/system parameters to include in the plant/system monitoring program
   • What are the acceptance criteria for plant/system parameters for sterile and non-sterile forms
   • How to define locations, sampling frequencies for individual plants/systems
   • What risk analysis methods are used to define locations, sampling frequencies
   • What is the scope of the periodic review of installations/systems
   • What are the typical elements of a periodic inspection report for installations/systems
   • What statistical methods should be used to analyse the monitoring data of installations/systems
   • What conditions must be met for statistical methods and data analysis to be reliable
   • How to define alarm/action limits in plant/system monitoring
   • How to define adverse events in plant/system monitoring
   • When corrective / preventive action should be taken
   • When an installation / system can be considered stable, under control
   • How to deal with difficult cases of non-standard behaviour
2. Evaluation of environmental monitoring
   • What is the purpose of trending environmental parameters
   • What adverse trends occur during environmental monitoring
   • What is the procedure for setting action/alarm limits
   • What types of control charts to use for sterile and non-sterile forms
   • What are the basic rules for using various control charts
   • What are the criteria for stability of environmental parameters
   • When and which additional configuration tests to use
   • What if data has a distribution other than normal and extremely asymmetric
   • What if the data is mostly equal to 0

Training hours: 8:15 AM – 3:30 PM

The training includes:

• comprehensive training materials
• certificate of participation
• coffee breaks and lunch (for on-site training)

Training types:

• online or on-site
• the format is indicated with the training date

For online trainings:

• live sessions via MS Teams
• real-time interaction with the instructor

Prerequisites:

• computer skills in a Windows environment

Price: 620 EUR net

Price for academic Statistica users with an active StatSoft Polska support agreement (-15%)*: 527 EUR net