Event Details

The FDA Safety and Innovation Act (FDASIA) is more than just a user fee schedule: there are other provisions that will change your manufacturing and product approval processes. Significant changes to law affecting FDA regulation have not occurred in over a decade and will have an impact on the Pharmaceutical Industry. These new requirements go into effect in 2013, are you prepared?

This webinar series will occur semi-annually, allowing you to benchmark where you and your company stand as the provisions of FDASIA go into effect over 2013. The webinars will provide details of the new law that directly impact the Pharmaceutical Industry from experts and the FDA. Use the FDASIA benchmarking webinar series to evaluate your company’s compliance to the new FDA expectations and requirements. Our experts will provide company leaders with the tools to stay on course for compliance as the FDA’s expectations evolve over 2013.

Some of the provisions that will be discussed are:

• New FDA Field Inspection Documentation Powers
• Facility Registration Requirements
• Unique Facility Identifiers
• Risk-Based Inspection Policy
• Impact on Generics
• Keep up with User Fees

The December 6, 2012 1:00 - 2:30 PM EST webinar will include,

• Steve Niedelman, Former FDA Deputy Associate Commissioner, Lead Quality System & Compliance Consultant, King and Spalding
• Jim O’Reilly, JD, Professor, University of Cincinnati
• Kathleen Culver, FDA Field Investigator and Drug Pre-Approval Manager, Cincinnati District (Invited)

Register now for December 6 »
Register for all 3 series and receive a 10% discount » 

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