My department is FDA-regulated and we are now running assays that
involve = the usage of the Flowcytometer.
My question: Is there anyone out there who had been audited (or
preparing = for one) by the FDA for assays run on the Flolwcytometer.
Audit areas would be: General GMP roles, system calibration,
maintenance, = validation, accuracy, documentation.....etc. Any piece
of information is very much appreciated. Thanks.
Osama Nabulsi Amgen Inc. Tel: (805)447-1594
CD-ROM Vol 3 was produced by Monica M. Shively and other staff at the
Purdue University Cytometry Laboratories and distributed free of charge
as an educational service to the cytometry community.
If you have any comments please direct them to
Dr. J. Paul Robinson, Professor & Director,
PUCL, Purdue University, West Lafayette, IN 47907.
Phone: (765)-494-0757;
FAX(765) 494-0517;
Web