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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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

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