Burkholderia Cepacia Complex and Aqueous Non-Sterile Drug Manufacture...

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Presented by

Dr John Metcalfe, Senior Pharmaceutical Quality Assessor at FDA and Dr. Doug Botkin at Charles River Laboratories

About this talk

Full title: Burkholderia Cepacia Complex and Aqueous Non-Sterile Drug Manufacture: Updates from a CDER Microbiologist's Perspective During this webinar, Dr. Metcalfe will: Provide a short background regarding FDA concerns pertaining to Burkholderia cepacia Complex (BCC) and the manufacture of non-sterile drug products Provide reference to pertinent areas of the 2021 FDA Draft Guidance for Industry-Microbiological Quality Considerations in Non-sterile Drug Product Manufacturing Present recent events in the US pertaining to BCC Explore recent FDA Warning Letters to address common industry questions regarding BCC and the manufacture of non-sterile drugs

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