On-Demand Webinar

Aseptic Vaccine Process Validation – Sterile Filter Focus

Duration: 1 Hour
Speaker: Michael Payne, Technical Biosafety Consultant, MilliporeSigma

Abstract: Aseptic processing is one of the toughest challenges in the vaccine industry. This webinar focuses on sterilizing filtration as a core of aseptic processing, and explains the best practices of process validation to assist compliance to the key regulatory guidelines. We will demonstrate how the combination of process validation and risk assessment contributes to deliver robust compliant aseptic processes especially when applied to sterilizing filtration. During this webinar you'll also learn:
  • the basic concepts behind process validation and aseptic processing
  • how to define a framework to structure process validation
  • the foundations of design, installation, and operational qualification
  • how to apply risk assessment to aseptic processing
  • the key regulatory guidelines for aseptic process validation
  • how compliant sterilizing filtration process qualifications contribute to the foundation of aseptic process validations
This practical webinar should be of specific interest to companies based in developing nations, where validation resources need careful prioritization. It will be beneficial to personnel from production, quality assurance, validation, technical support and engineering departments who are directly or indirectly involved in process validation.

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