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Fast Facts

IBC Training Course: Stability & Specifications for Biological and Biotechnology Derived Products

"The Interface between Clinical Studies, Analytical Methods and Process Control"

Nov 06, 2008 - Nov 07, 2008
Embassy Suites San Diego Bay, San Diego, California United States
 

Highlights

This course details the technical, regulatory and quality practices necessary for setting specifications for a wide variety of biological and biotechnological products. The roles of specifications and control limits in a total quality system are emphasized. Justification for the selection and validation of stability-indicating analytical methods and the establishment of suitable shelf-life specifications is discussed. The scope and objectives of specifications used to release and monitor pre-clinical lots, clinical lots and commercial lots are compared. The types of stability and validation data that should be generated to support specifications are presented and you will learn the regulatory requirements for setting specifications, and the rationale behind them.


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Event Profiles

Sponsors: IBC Professional Training Academy
Attendees: This course is designed for scientific, regulatory, and quality personnel involved in setting and supporting specifications and control strategies for biotechnology-derived drug products, including managers, supervisors and staff members from R&D, Product

Contact Details

Contact person: IBC Customer Service
Email address:
Event website: http://www.ibclifesciences.com/C5152/overview.xml
Phone: (800) 390-4078
Fax: (941) 365-0104

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