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HUM-MOLGEN
-> Events
-> Meetings and Conferences |
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August 08, 2012 |
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ComplianceOnline, Online Event
2012-09-12
Why Should You Attend: This course will provide an overview of the Stability studies required for registration of Vaccines.
The Stability Program for vaccines is similar to but has significant differences from a stability studies for Biologic Products. This webinar addresses overall requirements for a vaccine stability study, contrasting it with the requirements for Biologics and small molecule products. Areas Covered in the Seminar: - Overview of the WHO requirements for vaccine Stability studies.
- What are the requirement for stability studies on Intermediates?
- What are the requirement for studies after product approval?
- What are the list of methods appropriate for a vaccine stability study?
- What is the concept of Cumulative Age?
Event Details: Date: September 12 , 2012 Time: 10:00 AM-11:30 AM PDT Cost: $299 per attendee per computer terminal Registration: SIgn-Up on-line now. Add to your shopping cart.
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Organized by:
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ComplianceOnline |
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Invited Speakers:
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Dr. Subbarao, holds a Ph.D. in Bio-organic Chemistry. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. She has extensive experience in evaluation of analytical methods and method validation for products ranging from conventional drugs, well characterized proteins, vaccines, cell therapy and gene therapy products, ranging from pre-clinical phase to commercial phases. She has extensive expertise in setup of cGMP/GLP complaint Quality Systems for laboratory and stability programs as well as upgrade of existing Quality Systems for products during development and in commercial phase. She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. She serves on the AAPS Stability Focus Group Steering Committee.
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Deadline for Abstracts:
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2012-09-12
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Registration:
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For More Details: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702404?channel=hummolgen
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E-mail:
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referral@complianceonline.com
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