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.

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

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Partners located in the US (CA, FL, MA, MN) and Italy.