Designing Viral Clearance Studies for Biopharmaceuticals

Instructor: Kathryn Martin Remington
Product ID: 700220
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2007

Training CD / USB Drive

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Read Frequently Asked Questions

This Designing Viral Clearance training discuss the design and implementation of a viral clearance study that includes appropriate viruses to model existing and emergent viral threats and evaluates the impact of potential fluctuations in processing.

This presentation will discuss the design and implementation of a viral clearance study that includes appropriate viruses to model existing and emergent viral threats and evaluates the impact of potential fluctuations in processing parameters. Other key topics will include the importance of addressing viral safety during process development as well as validation of the scale-down model. In addition to a good theoretical background, this presentation will also provide practical information and data from real studies.

What Attendees will Learn:

  • Regulatory guidelines and their rationales
  • Process development with virus clearance in mind
  • Including mechanistically distinct steps for virus clearance
  • Validating the robustness of virus clearance and generic validations
  • Virus safety with respect to novel viruses
  • Determination of viral reduction factors for the process
  • Virus clearance expectations for early- and late-stage clinical trials

Who Will Benefit

This presentation will benefit biopharmaceutical professionals, managers and scientists involved in the following areas:

  • Biotech Research & Development
  • Process Development
  • Manufacturing
  • QC & QA
  • Process Validation
  • Regulatory Affairs
  • Biopharmaceutical Consultants
  • Outsourcing Professionals

Instructor Profile,

Kathryn Martin Remington Ph.D. is the Senior Manager of Virology at Cardinal Health in Research Triangle Park, North Carolina, a full-service solution provider to the pharmaceutical industry. Kathryn has over 20 years of experience in virology and has been involved in the viral safety of biologics for over 10 years. She has experience with both recombinant and human blood and plasma-derived products. She is the author of number scientific publications on viral safety and is a frequent speaker at conferences and workshops.

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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

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