May 1, 2012
By:David L. Rosen
How to handle and respond to a consent decree.
 |
April 1, 2012
By:James R. Johnson
FDA has created a dedicated cadre of foreign drug investigators and established permanent offices worldwide.
|
March 1, 2012
By:Greg T. Plante
Focusing on how risk affects the entire organization can improve the business bottom line.
|
January 1, 2012
By:Susan J. Schniepp
Contract organizations must have highly organized teams and plans to accommodate today's audits.
|
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.
|
September 1, 2011
By:Susan J. Schniepp
Why SOPs are rarely followed, often cited, and in great need of follow-through.
|
July 1, 2011
By:Carla Reed
Incorporating regulatory requirements into the product life cycle is crucial.
|
May 1, 2011
By:James P. Catania
A rigorous cost-benefit assessment can help to chart a cost-effective path forward.
|
March 1, 2011
By:James P. Catania
Executive management leadership is essential in the effective implementation of QbD.
|
| 
