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Basic Training

Global QA and Regulatory Compliance: The Business Case for an Enterprise-Wide Strategy

November 1, 2008

A centralized quality control strategy may be the best solution.

Building a Biotech Educational Infrastructure

March 22, 2007

Cities, counties, states; every political entity in our country is driving to develop a biotechnology presence in its respective region.

Quality Control: Operator Error: Is It Really the Root Cause of Performance Problems?

December 1, 2006

Conducting an analysis of the 4 Ms—man, machine, methods, and materials—enables companies to identify the true root causes of deviations.

The Laboratory Control System: Fulfilling cGMP Requirements

September 2, 2006

Reserve samples of test and control articles must be retained for at least one stability time point after the completion of the study.

Assuring the Effective Use of Standard Operating Procedures (SOPs) In Today's Workforce

September 2, 2006

SOPs are written job aids that detail the procedure of how to do a specific job task correctly.

A Systems-Based Team Approach to GMP Compliance

September 1, 2006

Companies faced with real or threatened FDA sanctions are usually least prepared to react effectively.

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