Burkholderia Cepacia Complex and Aqueous Non-Sterile Drug Manufacture: Updates from a CDER Microbiologist̵
Burkholderia Cepacia Complex and Aqueous Non-Sterile Drug Manufacture: Updates from a CDER Microbiologist’s Perspective
19th April 2023 | 10:00am EDT / 7:00am PDT / 3:00pm BST / 4:00pm CEST | Dr John Metcalfe, Senior Pharmaceutical Quality Assessor at FDA and Dr. Doug Botkin, Technology and Market Development Manager at Charles River Laboratories |WATCH FOR FREE
This webinar 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Provide reference to pertinent areas of the 2021 FDA Draft Guidance for Industry-Microbiological Quality Considerations in Non-sterile Drug Product Manufacturing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 about BCC
Explore recent FDA Warning Letters to address common industry questions regarding BCC and the manufacture of non-sterile drugs
Presented by Dr John Metcalfe, Senior Pharmaceutical Quality Assessor at FDA
Dr. John Metcalfe holds a BA in biology from Merrimack College in Andover, MA, and a PhD in microbiology from the University of Rhode Island. John spent 14 years teaching college microbiology courses before beginning a career at CDER in 2003. At the FDA, John is a Senior Pharmaceutical Quality Assessor (SPQA), where he performs a microbiological quality assessment of both sterile and non-sterile drug products. He is an FDA liaison to the USP Expert Committee on Pharmacy Compounding and is a published author in the area of drug product microbiological quality.
Followed by Dr. Doug Botkin, Technology and Market Development Manager at Charles River Laboratories
Dr. Doug Botkin is a technology and market development manager at Charles River Laboratories. He is a subject matter expert in the Microbial Solutions group, focusing on Accugenix products and services for microbial identification. Doug has over 24 years of experience in infectious disease research, spaceflight microbiology, and pharmaceutical microbiology, including working as a QC microbiologist at 503B outsourcing, cell and gene therapy, and non-sterile manufacturing sites. He holds a bachelor’s degree in biological sciences from Illinois State University and earned his PhD in microbiology and molecular genetics from the University of Texas Health Science Center at Houston.
Sponsored by Charles River Laboratories
For 30 years, Charles River has been dedicated to the development of precise, robust micro-QC solutions that help bring your products to market safely and efficiently. Our mission is to provide industry-leading scientific and technological advances that not only meet ever-changing regulatory guidelines but set a new standard in the way you perform testing. We’ve purposely built our portfolio to bring you progressive products and services that deliver accurate, relevant, and measurable data to fuel confident decisions on product quality for release. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture, and protects your reputation.
