The Cove Business Standards Discussion Forums
Monitor the Elsmar Forum
Courtesy Quick Links

Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services

International Quality Services

Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining

Ajit Basrur
Claritas Consulting, LLC

International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology

Single Post View
Old 25th September 2012, 02:28 PM

Total Posts: n/a
Re: EO Sterilization of Drugs in Custom Convenience Kits

Well have to admit I am embarrassed that this is the first I have heard of The Office of Combination Products. I am not sure that we fall in that catagory as it has never never been mentioned during a FDA or ISO Audit. Since our kits are convenience kits we do not hold 510K's. Thanks for the info. I am definatly checking it out.

Sponsored Links

The time now is 05:01 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.

Misc. Internal Links

NOTE: This forum uses "Cookies"