The GAMP 5 guide published by ISPE in 2008 has been a reference document for both health authorities and industry for the management and validation of computerized systems. The GAMP 5 guide has been one of the documents published by ISPE with more relevance and impact in the sector.

Due to new developments in computerized systems, ISPE’s GAMP CoP Global Steering Committee, of which ISPE Iberia is a member, together with the GAMP CoP ERB (Editorial Review Board), initiated a comprehensive review of the GAMP Guide in 2017.

As a result of the intense revision work of these last years, the second edition of the GAMP 5 guide was published last August.
The ISPE Iberia GAMP team is proud to present this new edition at Farmaforum on Wednesday, October 5, 2022, from 4:45pm to 5:15pm. 

In the presentation of this new guide, the changes it brings, the implication in the design, its implementation and the implications in validation for the pharmaceutical and medical device industry will be listed.

In addition, for all attendees of the presentation event of the second edition of GAMP 5.0, organized by the local GAMP CoPs, ISPE offers a 10% discount for the purchase of the new guide.