Thursday, 13 September 2018

Burkholderia cepacia - Risks in Context for Non-Sterile Pharmaceutical Products (Webinar)


Drug manufacturers of non-sterile, water-based drug products have seen recent product recalls due to Burkholderia cepacia complex. Regulatory agencies expect pharmaceutical manufacturers to be testing environments, water and products for the organism and putting remedial measures in place. In order to test effectively, microbial methods need to be suitably qualified. The qualification of methods is challenging. Attend this webinar to learn more about this microorganism of concern, and to learn about its origins, risk factors, means of mitigation and methods of detection.

Details:

Date: Thursday, 20 September 2018 | Time: 10:00 AM PDT, 01:00 PM EDT | Duration: 60 Minutes

Burkholderia cepacia complex (BCC) organisms can survive or multiply in a variety of non-sterile and water-based products because it is resistant to certain preservatives and antimicrobial agents. This makes the organism a risk in terms of non-sterile aqueous products. Detecting BCC bacteria is also a challenge and requires validated testing methods that take into consideration the unique characteristics of different BCC strains. This webinar discusses where the organism may be found, how to detect it and what to do if it is present in the manufacturing environment.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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