Content
Statistical methods in 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 provide an overview of the most important methods and their application.
The seminar examines the question of how experimental design, statistical methods and sampling rationales can be linked together in order to achieve a statistically valid assessment with reasonable effort. The implementation of the risk-based approach of DIN EN ISO 13485 in sampling rationales is presented. Another aspect of the seminar is the monitoring of processes as part of process monitoring and appropriate sampling procedures.
Topic overview
- Normative requirements (21 CFR 820, DIN EN ISO 13485)
- Statistical basics
- Design of validation studies related to statistics
- Methods for evaluating processes with variable characteristics (ISO 16269-2 and others)
- Evaluation of processes with attributive characteristics
- Risk-based approach and sampling rationale
- Procedures for monitoring processes and conducting checks on validated processes
target group
Process developers, test planners (production monitoring and product release) and process managers (process validation).
Prior knowledge
Not required.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
Online
