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The training focuses on the use of basic statistical methods and tools in risk management, in accordance with the recommendations of Annex 20 “Quality Risk Management” of the European Guide to Good Manufacturing Practice for Medicinal Products. Participants will practice selected statistical tools, learn their practical application in risk assessment and control, and analyze the current level of implementation of these methods in their organizations.
The training provides practical knowledge necessary for the effective implementation of a data-driven approach within the quality system.
Join a group of participants from different companies and discover industry best practices.
Currently no scheduled dates.
Do you have any questions or are you interested in this topic?
Contact us to discuss the possibility of delivering this topic as an open training.
Order a training tailored to the needs of your organization.
Stationary / On-line
The day may be established
Individual pricing
For in-company training, the proposed program is a preliminary suggestion and can be freely adapted to the individual needs of the company. INTRODUCTION TO STATISTICAL METHODS AND RISK MANAGEMENT
Content:
Exercises:
In this short introductory part, information will be presented regarding the needs related to the use of statistics in process control and risk management
The basic standards describing statistical methods will be presented
The group will understand why the use of statistics in risk management is beneficial
BASIC STATISTICAL TOOLS
Content:
Exercises:
This part of the training is an introduction to statistics
Concepts such as standard deviation and median, among others, will be presented
The creation and interpretation of a histogram, correlation diagram, and Pareto analysis will be demonstrated, along with the use of these tools in risk management in pharmaceutical companies
Participants will also learn how to properly plan quality control (including selection of sample size) based on AQL
CONTROL CHARTS – INTRODUCTION
Content:
Exercises:
Training participants will become familiar with a wide range of control charts that can be used in the company
Examples of their application in processes carried out in pharmaceutical companies will be presented and discussed
Exercises may be conducted using data provided by the Company
NON-STANDARD CONTROL CHARTS
Content:
Exercises:
How to monitor a process that is non-standard?
In this part of the training, participants will become familiar with non-standard control charts that enable the monitoring of atypical processes, which may be typical in the pharmaceutical industry
QUALITY CAPABILITY ASSESSMENT OF PROCESSES AND MACHINES
Content:
Exercises:
Since control charts provide information only about process stability (i.e., orderliness), indicators are needed that relate the collected results to established specification limits
This part of the training is devoted to the numerical, straightforward presentation of process variability in relation to requirements set by customers or technologists
The training takes the form of workshops supported by a multimedia presentation and supplemented with exercises. The theoretical part is interwoven with numerous examples tailored to the industry in which the participants work. The training may be conducted based on real company examples – analysis of a selected process. The pace of the training and the difficulty of the discussed topics are adjusted to the participants’ level of advancement, and the scope of the training can be tailored to the specific nature of your company.
An extension of the training may be a one-day course in DOE (Design of Experiments).
After the training, each participant will receive a certificate confirming completion of the training.
In case you encounter any issues with filling or sending form, please contact our team +48 71 355 18 08 or reach us through mail szkolenia@proqual.pl
PROQUAL Management Institute
B. T. Greber Spółka Jawna
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