FDA Food Safety Presentation- Part 11 Redirection

At a Food Safety Conference FDA’s CDRH Software Compliance and Part 11 Representative (John Murray) gave a new presentation on FDA’s changes in its approach to Part 11. The presentation is an improvement to a presentation Mr. Murray gave at the March 2003 AAMI standards conference. The slides from this presentation are at the link provided.

Mr. Murray verbally expressed that this is a significant shift and he believes FDA is committed to resolving the problems and burden of prior Part 11 interpretations.

A Part 11 Redirection Q&A presentation by Alan Kusinitz of SoftwareCPR and an implementation presentation by Carl Wyra presented and a presentation by Mr. Murray at the March 2003 AAMI Standards Conference are also available in the library portion of www.softwarecpr.com. Just search for “redirection”.

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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