Event

The New CBER Sterility – A Comprehensive Review of Sterility Testing

March 15, 2012 iCal

Time: 12:00-2:00pm
Location: LIVE, INTERACTIVE TRAINING WEBINAR; IN YOUR OFFICE

On Tuesday, June 21, 2011, the FDA (CBER) released proposed Amendments to the Sterility Test Requirements for Biological Products. The proposed rule change “is intended to provide manufacturers of biological products great flexibility and to encourage use of the most appropriate and state-of –the-art test methods for assuring the safety of biological products”.

The objective of this live and interactive Tungsten Shield training webinar is to explore the proposed amended §610.12 which should promote improvement and innovation in the development of sterility test methods, to assess the challenges of novel products that may be introduced to the market in the future and to potentially enhance sterility testing of currently approved products. This Webinar will also explore how this proposed change impacts the Ph. Eur 2.6.1, USP<71> Sterility Tests, the PET Guidance for Industry (December 2009) and the proposed changes to USP<823> Radiopharmaceuticals for Positron Emission Tomography-Compounding.

Learning Benefits:

- A determination of the most appropriate and state-of-the-art test methods for §610.12

- Examination of the elimination of specified sterility test methods, culture media formulae and culture media test requirements

- The elimination of specified membrane filtration procedure requirements for certain products

- Elimination of specified sterility test requirements for most bulk materials

- Modification of the repeat sterility test requirements to include only a single repeat test

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