ComplianceOnline

Biopharmaceutical Viral Safety from Process Design through Validation

Instructor: Kathryn Martin Remington
Product ID: 700827
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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This webinar will provide valuable background for those who need to evaluate viral clearance data.

Description

This presentation will review conventional and innovative viral clearance methodologies.

Knowing the ever-present threat of existing and emergent viral pathogens, the FDA, EMEA and other regulators expect that manufacturing processes for biopharmaceuticals have the capacity to remove or inactivate potential viral contaminants. The viral clearance capacity of a manufacturing process should be considered at process inception, optimized during development and ultimately validated. This presentation will review conventional and innovative viral clearance methodologies. Case studies will be used to demonstrate optimization of the viral clearance capacity of process step. Finally, the design of a viral clearance study to accurately model the clearance achieved in your manufacturing process will be discussed. In addition to a good theoretical background, this presentation will also provide practical information and data from real studies.

Areas Covered in the seminar:

  • Process development with virus clearance in mind.
  • Mechanistically distinct steps for virus clearance.
  • Scale-down models.
  • Virus safety with respect to novel viruses.
  • Typical and innovative viral clearance methods.
  • Viral clearance expectations and stage of development.

Who will benefit:

This webinar will provide valuable background for those who need to evaluate viral clearance data. The course will benefit individuals such as:

  • Process Development Scientists
  • Manufacturing
  • QC & QA Scientists
  • Research & Development
  • Regulatory Affairs
  • Consultants

Instructor Profile:

Kathryn Martin Remington, Ph.D., is the Senior Manager of Virology at Catalent Pharma Solutions (formerly Cardinal Health) in Research Triangle Park, North Carolina, a full-service solution provider to the pharmaceutical industry. She has worked in research studying drug resistant AIDS viruses and was previously the Section Head of Viral Validation for Bayer HealthCare. Kathryn has over 20 years of experience in virology and has been involved in the viral safety of biologics for over 10 years. She is the author of number scientific publications on viral safety, is a frequent speaker at conferences and workshops, and is a member of the PDA/FDA/EMEA Virus Spike Task Force.

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