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Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.
November 02, 2012
Key talks from the recent PDA/FDA regulatory conference highlight room for improvement.
July 02, 2012
How FDA, USP, and ICH have redirected industry practice.
April 02, 2012
The contract provider needs to know as much as the NDA holder.
February 01, 2012
The author describes an equation that can be used to define the Quality relationship between a contract manufacturing organization and a client, including how to factor in both party's needs and regulatory commitments.
December 02, 2011
Contract organizations must have highly organized teams and plans to accommodate today's audits.
September 02, 2011
After a series of structural changes, the author wonders whether USP is undergoing an identity crisis. USP CEO Roger L. Williams responds.