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”.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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