Good Automated Manufacturing Practices 4 (GAMP)

The Good Automated Manufacturing Practice (GAMP) organization is now at Version 4. The original GAMP initiative was based in Europe and was focused on guidance for computer systems and equipment suppliers to the pharmaceutical industry. It provided guidance and templates on computer system validation. GAMP includes a more risk based approach and expands its scope in a number of areas. The GAMP website is at the link provided. There are also a series of presentations on GAMP 4 on the GAMP 4 Launch Presentations page. The link to this page is near the bottom of the GAMP 4 page.

Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
Non refundable but transferable.

Or just email training@softwarecpr.com for more info.

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