November 1, 2012
By:
J. Paul Catania
Understanding overall supplier capability versus the critical-to-quality attributes of your product can reduce both risk and cost.
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June 1, 2012
By:
Susan J. Schniepp
The contract provider needs to know as much as the NDA holder.
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May 1, 2012
By:
David L. Rosen
How to handle and respond to a consent decree.
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April 1, 2012
By:
James R. Johnson
FDA has created a dedicated cadre of foreign drug investigators and established permanent offices worldwide.
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March 1, 2012
By:
Greg T. Plante
Focusing on how risk affects the entire organization can improve the business bottom line.
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January 1, 2012
By:
Susan J. Schniepp
Contract organizations must have highly organized teams and plans to accommodate today's audits.
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November 1, 2011
By:
Ian Uydess, Chet Meyers
In a culture of quality, it is important that employees adopt this mindset, not because they have to, but because they understand the importance.
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