FDA CDRH Inspection Guide Lists FDA SW Contacts

The final Device Center Inspection Compliance Policy Guide (provided at the link above and in the Library on this site) Part VI, Page 11, lists the following as points of contact related to software:

“i. Questions regarding compliance of product software, stand alone software, process equipment software or the Year: 2000 Problem:
Stewart Crumpler
Office of Compliance Software Expert, HFZ-340
Telephone: (301) 594-4659 ext. 119”

Mr. Crumpler is also listed along with Paul Motise of ORA as contacts for Part 11 Electronic Records;Signatures questions.

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

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