Friday May 18, 2012 Friday May 18, 2012
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Drug products manufactured using biotechnology processes such as fermentation and purification require additional controls for safety, purity and potency than small molecule drugs manufactured using chemical synthesis processes. Therapeutic protein drug products are conducive to microbial growth. It is critical to implement a microbial control strategy that will reduce the likelihood of bioreactor contamination and prevent microbial growth in in-process intermediates, buffers, media and final bulk material. This webinar will specifically discuss these controls and describe how the FDA evaluates the microbial control strategy during review of Biologics License Applications (BLAs) submitted to CDER and during pre-license and pre-approval inspections. Microbial control will also be discussed for the aseptic processing and fill of the final drug product, in particular prior to sterile filtration.
This presentation is targeted to Microbiologists and those in Quality, Regulatory, and Compliance.
Anastasia Lolas is an independent consultant and the owner of Visionary Pharma Consulting LLC. Anastasia provides consulting services to the pharmaceutical industry regarding regulatory and compliance issues related to product quality microbiology of small molecules and therapeutic proteins. Previously, she was a Microbiologist with the Biotech Manufacturing Team in the Division of Manufacturing and Product Quality at CDER/FDA and a Microbiology Reviewer with the New Drug Microbiology Staff in the Office of Pharmaceutical Science at CDER/FDA. In her 6 years at the FDA, Anastasia evaluated numerous new drug applications and biologics license applications and conducted pre-license and pre-approval inspections of therapeutic protein manufacturing facilities. Anastasia holds a B.S. in Biology from Virginia Polytechnic Institute and State University and a M.S. in Food Science from the University of Illinois at Urbana-Champaign. Prior to joining FDA in 2005, she was employed at Nestlé Waters North America. Anastasia is the Meeting Chair of the PDA Capital Area chapter and a member of the PDA Letter Editorial Committee.
Single Attendee: CAD $195.00
Group of 5 or less per location: CAD $400.00
Group of 6 to 10 attendees per location: CAD $750.00
Group of 11 to 20 attendees per location: CAD $1250.00
Single attendee refers to single participant at a single computer/login.
Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.
Please contact us at webinar@ipacanada.com for multiple-location group rates or any other enquiries.
