I have recently associated myself with a medical device company after 9 years with a neutraceutical manufacturer. I am a certified GMP trainer and have a good understanding of GMPs and quality systems. I'd like some recommendations for a Medical Device/FDA seminar or series of 2-3 seminars over a 5 day period. The only group I've found so far is Stat-a-Matrix and they are offering:

"Understanding FDA's Medical Device Quality System Regulation" (2-days)
"Understanding an ISO 13485 Quality Management System" (1-day)
"FDA's Quality System Inspection Technique (QSIT) (1-day)
"Introduction to Process Validation" (1-day)

Hopefully, those of you with experience will have some good sources for me to investigate.

Thanks, Ted :yes:

Ted,

You may also want to look at SAI Global's (formerly Excel Partnership) offering of courses related to medical devices. I attended their seminar called Quality System Regulation for the Medical Device Industry in 2002 and found it quite educational. If memory serves, it was a 2-day seminar. (I'm not affiliated with SAI Global/Excel Partnership in any way.)

ASQ may have additional information on their web site, in case you haven't looked yet. The FDA may also have information on their site.

Hope this helps.

also try www.aami.org

Phil

Ted,

Another place you might try is located here:

http://www.caliso9000.com/medical_device_GMP.html

Have a nice day!