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At AAMI’s International Standards Conference on March 11 2003 FDA’s CDRH Software Compliance and Part 11 Representative (John Murray) gave the first presentation on FDA’s changes in its approach to Part 11. The slides from this presentation can be viewed at this link: AAMI-AK-Part11pres-031103-b
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. He mentioned that FDA will be taking steps to train its inspectors in the new approach.
A Part 11 Redirection Q&A presentation by Alan Kusinitz of SoftwareCPR and an implementation presentation by Carl Wyra were presented as part of the session with Mr. Murray.
C. Wyrwa’s Part 11 Implementation Presentation can be viewed here: AAMIPart11-CWyrwaPresentation031103