2019 New USP 60 Microbiological Examination of Nonsterile Products Tests for B Cepacia Complex
: 22 Aug 2019
Sector: Cosmetic/Personal Care, Pharmaceutical
Type: Training, Webinar
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.
- A review of the pertinent history of B. cepacia/complex.
- Extensive review of the process involved in the isolation and identification of B. cepacia/complex.
- Explore the “new” recommended medium for propagation of this microorganism and its complex.
- Learn why USP<60> does not provide a sufficient identification (genus/species).
- Use of B. cepacia within USP<1111> as a potential monograph addition.
- Experience what companies have encountered with recalls, form FDA 483s and warning letter examples.
- Case studies of warning letters with B. cepacia/complex.
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.