content
Statistical methods for the validation of processes are a requirement of the standard. The aim of this seminar is to classify statistical methods in terms of their importance in process validation and to give an overview of the most important methods and their application. The seminar addresses the question of how test design, statistical methods and sampling rationales are linked in order to be able to arrive at a statistically reliable evaluation with reasonable effort. The implementation of the risk-based approach of ISO 13485 in sampling rationale is presented. Another aspect of the seminar is the monitoring of processes within the framework of process monitoring and the appropriate sampling procedures.
topic overview
- Normative requirements (21CFR820; DIN EN ISO 13485)
- Statistical Basics
- Design of validation studies related to statistics
- Methods for evaluating processes with variable characteristics (ISO16269-2 and others)
- Evaluation of processes with attributive characteristics
- Risk-based approach and sampling rationale
- Methods for monitoring processes and conducting tests on validated processes
target group
Process developers, test planners (production monitoring and product release) and process managers (process validation).
previous knowledge
Not mandatory.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
