May 22 2014
2:00 PM EDT
The recent series of inspections of compounding pharmacies by the FDA has shown that the BET test is poorly understood in terms of both its goals and its execution. This complimentary webinar that will provide the pharmacist with a background to the test and its value.
USP <85> Bacterial Endotoxins Test and USP <151> Pyrogen Test are the two chapters that offer advice on testing for pyrogens. USP chapter <85> describes gel-clot and photometric tests for bacterial endotoxins using limulus amebocyte lysate (LAL) reagent. Endotoxin detection by LAL reagent, which is derived from blood cells of the Atlantic horseshoe crab, is enabled by an enzymatic cascade similar to that of human blood coagulation. USP <151> still describes the parameters of the test using three rabbits and measuring their temperature after administering a known dose of the drug.
Speaker
- Ken Latta, R. Ph., BS Pharm, FIACP, FACA, Senior Associate for Gates Healthcare Associates, Inc
Ken Latta, received his BS in Pharmacy from the University of North Carolina in 1978. Following graduation, he stayed on at Duke University Medical Center as a pharmacist. Mr. Latta was a staff pharmacist at Duke University Medical Center from 1978 through 1989. He then became the lead pharmacist at the Acute Pain Service at the medical center, a position he would hold until 2000. During this time, he served on several national committees with the American Pain Society and took part in several pain initiatives. Mr. Latta is a Senior Associate for Gates Healthcare Associates, Inc. as well as being a consultant to the North Carolina Board of Pharmacy. He teaches courses in sterile and non-sterile compounding throughout the US, Canada, and Australia with Medisca Network. He is a nationally recognized expert in pharmacy compounding, clean room design, process control, validation and pain management. He has written and taught extensively on these topics. In 2006, Mr. Latta became involved in PCAB
® (Pharmacy Compounding Accreditation Board) by being a member of the Standards Committee for 6 years and is still actively involved as a surveyor.
To register for this complimentary webinar,
click here.
This webinar is sponsored by Charles River.
quoted from here
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