ComplianceOnline

Viral Validation for Biopharmaceuticals

Instructor: Kathryn Martin Remington
Product ID: 700187
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
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

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Viral Validation webinar provide information on potential viral contaminants and their risks, expectations of regulatory agencies, effective methods of viral inactivation/removal, and important considerations in the design of a viral validation.

Ensuring the safety of the manufacturing process for a biopharmaceutical and meeting regulatory requirements can be complicated and costly.Understanding the rationale behind viral safety can help to make viral validation studies more than just a box to check on the way to licensure of a product. Viral safety should be considered throughout a manufacturing process, from source materials to setting processing limits. This presentation will provide information on potential viral contaminants and their risks, expectations of regulatory agencies, effective methods of viral inactivation/removal, and important considerations in the design of a viral validation study. In addition to a good theoretical background, this presentation will also provide practical information and data from real studies.

What Attendees will Learn:

  • Potential viral contaminants, including emergent viruses, and their risk
  • Ensuring viral safety in source materials
  • Regulatory guidelines and their rationales
  • Conventional and innovative methods of virus inactivation and removal
  • Assays to detect viruses in clearance studies and their advantages and disadvantages
  • Appropriate virus spikes
  • Including robustness viral clearance studies

Who Will Benefit:

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

  • Process Development Scientists
  • Research & Development
  • Manufacturing
  • QC & QA
  • Process Validation

Instructor Profile:

Kathryn Martin Remington, Ph.D. is the Senior Manager of Virology at Cardinal Health in Research Triangle Park, North Carolina, a contract laboratory that performs biosafety testing and viral clearance studies for biopharmaceutical products. 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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Refund Policy

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.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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