Devices Data

ISPE GAMP®5 Second Edition: Enabling Innovation - CSA

Online-Seminar | Background information and details about ISPE GAMP®5 – second edition

  • This seminar will be held in English
  • ISPE GAMP®5 – Good Practice Guide - Enabling Innovation (2021)
  • Further CSV updates, e.g. of the US-FDA – Guidance for Industry: Computer Software Assurance (CSA) – Draft version for comment from September 2022

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.

More information



09:00 - 16:30 Uhr


comes compliance services
Markus Roemer


Online-Veranstaltung / Webinar