After celebrating GAMP’s 30th anniversary in 2021, the GAMP Global Steering committee and ISPE are proud to present the Second Edition of GAMP® 5 which will be available Summer of 2022. GAMP 5 Guide–A Risk-Based Approach to Compliant GxP Computerized Systems was initially published in 2008. A GAMP 5 Second Edition has been developed based on comprehensive reviews of GAMP 5 content performed in 2017 and early 2020 by the GAMP CoP Global Steering Committee and the GAMP CoP ERB (Editorial Review Board).
The primary purpose and objective of this revision is to provide updates, clarify the relationship between GAMP 5 and the GAMP® 5 Guide: Records and Data Integrity, acknowledgment of current FDA work on computer software assurance (CSA), and an updated, dynamic, and evolving set of Appendices.
Join the ISPE Boston Chapter Educational Program on August 18th in Cambridge, MA to learn more about how volunteer experts and regulators from the ISPE family collaborate through GAMP on a range of software and computerized systems challenges in a highly quality driven and regulated space. Hear from contributing authors, reviewers, and the editorial team about the highlights of this second edition.
We also hope to shortly confirm a lively panel discussion with two invited FDA speakers from CDER and CDRH, who are both passionate about risk-based Validation of software and have worked closely with the editorial team on the upcoming ISPE guide.
AGENDA:
1:30pm Welcome
• Overview of the ISPE GAMP Community of Practice
• Overview of the ISPE GAMP® 5 Guide, 2nd Edition
• Panel Discussion on critical thinking and risk-based approach to computer system validation (FDA invited)
• ISPE GAMP® 5 Guide, 2nd Edition new chapters/appendices on critical thinking and risk-based testing
• How to be involved in ISPE GAMP, Special Interest Groups, and local Communities of Practice
5:30-7:00pm Networking Session