OR WAIT null SECS
June 01, 2012
The contract provider needs to know as much as the NDA holder.
May 01, 2012
How to handle and respond to a consent decree.
April 01, 2012
FDA has created a dedicated cadre of foreign drug investigators and established permanent offices worldwide.
March 01, 2012
Focusing on how risk affects the entire organization can improve the business bottom line.
January 01, 2012
Contract organizations must have highly organized teams and plans to accommodate today's audits.
November 01, 2011
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 01, 2011
Why SOPs are rarely followed, often cited, and in great need of follow-through.
July 01, 2011
Incorporating regulatory requirements into the product life cycle is crucial.
May 01, 2011
A rigorous cost-benefit assessment can help to chart a cost-effective path forward.
March 01, 2011
Executive management leadership is essential in the effective implementation of QbD.