New Draft General Chapter USP <60> - Tests for Burkholderia Cepacia Complex
: 11 Dec 2019
Type: Training, Webinar, Seminar
Burkholderia cepacia and its BCC Complex are bacterial species that are ubiquitous in nature and often found as a frequent recall issue based upon CDER data. Pharmaceutical products that are contaminated with B. cepacia and/or its Complex may pose serious issues to infants, elderly and immunocompromised individuals. Preventing B. cepacia contamination in drugs by addressing the potential sources of this Complex in a drug manufacturing operation is an important public health goal.
B. cepacia is robust in nature and poses a relatively high patient risk when present in manufacturing equipment, components, or the process water used in manufacturing pharmaceutical products.
The objective of this live, interactive training webinar is to explore the various issues surrounding the history of B. cepacia and its Complex and examine solutions to common microbiological problems. It will discuss the draft General Chapter USP<60>, media that is proposed, genotypic consideration as well as recalls, FDA 483s and Warning Letters. Please plan to bring an interdisciplinary team to this training session to explore how knowledge regarding this contaminant and its Complex may assist you in your facilities and minimize it as an objectionable microorganism/group.