NOV 03, 2016 9:00 AM PDT

Risk Mitigation and Management to ensure Virus Safety of Biopharmaceuticals: Regulatory Perspectives and Industry Best Practices

Sponsored by: Sartorius, Sartorius
Speaker
  • Field Marketing Manager
    Biography
      Hazel Aranha is a biopharmaceutical industry professional with over 30 years' experience in industry, academia and consulting. She is a well-acknowledged expert in the area of virus and prion clearance from biopharmaceuticals. She has provided consulting services in the US, Europe and Asia. She teaches courses on ‘ensuring virus safety of biologicals', as well as other topics including: ‘Good Clinical Practices' (GCP), ‘Good Manufacturing Practices (GMP), ‘Downstream Processing', ‘Navigating the Drug Development Cycle', and ‘Effective Biomedical Writing'.
      Hazel has a Master's degree in Virology, Ph.D. in Environmental Microbiology and holds Regulatory Affairs Certification (RAC) for both the US and European Union. She has to her credit 2 books, over 45 publications, and 4 book chapters. Her past assignments have included positions at Catalent Pharma Solutions, Wyeth Vaccines (Pfizer), and Pall Corporation.

    Abstract
    DATE: November 3, 2016
    TIME:  9:00AM PT, 12:00PM ET


    Patient safety is at the core of biopharmaceutical manufacturing operations. Ensuring virus safety of biopharmaceutical products poses logistical challenges for several reasons including: nature of raw materials, non-homogenous distribution of raw materials, and limitations with virus detection methods.
    This webinar will address the regulatory basics in virus safety assurance, the need for incorporation of multiple orthogonal virus clearance strategies, and design of validation studies. Case studies will be presented to demonstrate industry best practices. In addition to risk management in downstream operations, the importance of risk mitigation in upstream operations to minimize bioreactor contamination events will be discussed.

    Learning Objective 1:  Learn about the  regulatory basics in virus safety assurance of biopharmaceutical products.

    Learning Objective 2:  Learn about common virus clearance technologies used in the biopharmaceutical industry.
     

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