- The regulatory frameworks you need to know - Acceptance criteria in validation
- Significance and interpretation of deviations
- How to monitor the success of method transfer and avoid common pitfalls - Statistical expertise for your method validationMaster GMP-compliant method validation and analytical method transfer in one focused online seminar. Walk away with practical knowledge of current ICH and FDA requirements, solid statistical foundations, and the confidence to avoid common pitfalls in method transfer.LernzieleThis seminar provides a platform for discussing current challenges in method validation and analytical method transfer with industry experts.
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The focus is on chemical substances. Methods for substances of biochemical or microbiological origin are not covered.-
After completing the seminar, you will be familiar with the regulatory requirements in the EU and the USA, and you will have exchanged insights on acceptance criteria in method validation and analytical transfer. The significance and interpretation of deviations will be illustrated through practical examples. You will also gain awareness of common pitfalls in method transfer.
The statistics module clarifies how different types of analytical data are evaluated.ZielgruppenAre you a laboratory manager looking to exchange views on current challenges in method validation and transfer with industry experts?-
Are you an experienced laboratory professional seeking an update on current working practices?- Then this seminar is designed for you!
It is aimed in particular at specialists and managers in the fields of R&D, quality control, and analytics.
- The regulatory frameworks you need to know - Acceptance criteria in validation
- Significance and interpretation of deviations
- How to monitor the success of method transfer and avoid common pitfal... Mehr Informationen