A thorough investigation of all possible causes of deviations should be performed.
Feb 2, 2013
By:
Susan J. Schniepp
A thorough investigation of all possible causes of deviations should be performed.
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Key talks from the recent PDA/FDA regulatory conference highlight room for improvement.
Nov 2, 2012
By:
Susan J. Schniepp
Key talks from the recent PDA/FDA regulatory conference highlight room for improvement.
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How FDA, USP, and ICH have redirected industry practice.
Jul 2, 2012
By:
Susan J. Schniepp
How FDA, USP, and ICH have redirected industry practice.
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The contract provider needs to know as much as the NDA holder.
Apr 2, 2012
By:
Susan J. Schniepp
The contract provider needs to know as much as the NDA holder.
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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.
Feb 1, 2012
By:
Susan J. Schniepp
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.
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Contract organizations must have highly organized teams and plans to accommodate today's audits.
Dec 2, 2011
By:
Susan J. Schniepp
Contract organizations must have highly organized teams and plans to accommodate today's audits.
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After a series of structural changes, the author wonders whether USP is undergoing an identity crisis. USP CEO Roger L. Williams responds.
Sep 2, 2011
By:
Susan J. Schniepp
After a series of structural changes, the author wonders whether USP is undergoing an identity crisis. USP CEO Roger L. Williams responds.
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Why SOPs are rarely followed, often cited, and in need of follow-through.
Jun 2, 2011
By:
Susan J. Schniepp
Why SOPs are rarely followed, often cited, and in need of follow-through.
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What to do when your CMO changes the manufacturing equipment line.
Mar 2, 2011
By:
Susan J. Schniepp
What to do when your CMO changes the manufacturing equipment line.
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