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Featured Articles

September 2009

Increasing Efficiency Through Lean Principles

Lean manufacturing is an operational strategy oriented toward achieving the shortest possible cycle time by eliminating waste. It is derived from the Toyota Production System and is designed to increase value-added activity by eliminating waste and reducing incidental work. The lean technique often decreases the time between a customer order and shipment but its principles are adaptable to any process as long as that process has a beginning and an end point. Lean manufacturing is designed to radically improve profitability, customer satisfaction, throughput time and employee morale. Each of these factors are important in an organization whether the end goal is a profit or a not-for-profit return. The benefits of lean manufacturing are generally lower costs, increased quality (already high on the list for regulated organizations), and shortened lead times.

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Writing and Maintaining SOPs: Drudgery or Delight?

SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training for all affected parties. SOPs and related training help ensure compliance with internal processes and also help to ensure compliance with regulating bodies, such as the FDA.

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AABB Annual Meeting & TXPO 2009
October 24-27, 2009, New Orleans, LA

GMP & FDA Compliant Quality & Doc Systems 2009
November 19-20, 2009, Munich, Germany

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Did you know that according to a recent FDANews article Margaret A. Hamburg, the Commissioner of Food and Drugs, recently outlined her plan to "prevent harm to the American people" through fast and aggressive FDA enforcement?

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