23. November 2023 – Expert Training
Learn about the background, effects and details regarding the current changes and extensions of the ISPE GAMP®5 – Second Edition – which was released in August 2022.
In 2008, ISPE set GAMP®5 as the recognized state of science and technology regarding so-called computer system validation (CSV) in the GxP environment.
The volume ISPE GAMP®5 – Second Edition, published in August, is a deliberate extension of the proven standard.
With the expansion in the form of a second edition, current topics are to be presented even more clearly, pragmatically and purposefully.
Validation should be based more on process, data and system knowledge and these should be even more in the foreground of agile system development and the validation approach.
- ISPE GAMP®5 – Second Edition – Scope and Change Overview
- History and structure of ISPE GAMP®5
- Annexes of the ISPE GAMP® (Management, Development, Operations, Special Interest)
- ISPE GAMP® Good Practice Guides (incl. RDI) and examples of “Critical Thinking” and Data Flow Diagrams
- ISPE GAMP®5 – Good Practice Guide – Enabling Innovation (2021) and others
- Further CSV updates, e.g. from the US-FDA – Guidance for Industry: Computer Software Assurance (CSA) – Draft version for comment from September 2022 or EU Annex 11 – concept paper
Register now at: Register to ISPE GAMP 5 second edition Online Training
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