RE- FDA regulations & Flowc

• Messages sorted by: [ date ][ thread ][ subject ][ author ]
• Next message: Dr. Gregor Rothe: "CD33+++ T cells"
• Previous message: Thomas Delohery: "the new BD MAC systems..."

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

• Next message: Dr. Gregor Rothe: "CD33+++ T cells"
• Previous message: Thomas Delohery: "the new BD MAC systems..."

CD ROM Vol 2 was produced by 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:(317) 494-0757; FAX (317) 494-0517; Web http://www.cyto.purdue.edu EMAIL robinson@flowcyt.cyto.purdue.edu