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Reshaping Pharmaceutical Quality

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(ISPE: Tampa, Florida) -- The June 2008 issue of the Journal of Pharmaceutical Innovation (JPI) is publishing the first scientific pape

Safety, Quality, and Environmental Standards Study

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(Deloitte: New York) -- Heightened publicity over product recalls has made product safety, as well as product quality and environmental standa

Dress Rehearsal

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I recently had a client who went through a pre-assessment in anticipation of his company’s certification audit. It’s kind of like a dress rehearsal for the real thing.

NCQA Program to Evaluate Health Promotion

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(NCQA: Washington) -- The National Committee for Quality Assurance today released for public comment proposed standards and measures for a new Wellness and Health Promotion (WHP) product evaluation suite.

ISO Standard for IT Governance

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(ISO: Geneva) -- Because inadequate information technology (IT) systems can hinder the performance and competitiveness of organizations or expose them to the risk of not complying with legislation, the new ISO/IEC 38500 standard provides broad guidance on the role of top management in relation to th

Noise Thermometry

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Ph

What’s in It for Me?: Work Instruction No. 3

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ABC Company Work Instruction

Purpose: To determine root cause for external nonconformance (customer complaints), internal nonconformance (rework, sort, subcontractor), and quality audit nonconformance findings.

What’s in It for Me?: Work Instruction No. 1

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ABC Company Work Instruction

Purpose: To initiate a DMR for internal nonconformance, subcontractor nonconformance, rework, or sorting.

What’s in It for Me?

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As a consultant, I have been asked numerous times by management teams that are considering quality management systems (QMSs) such as ISO 9001,

What’s in It for Me?: Work Instruction No. 3

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ABC Company Work Instruction

Purpose: To determine root cause for external nonconformance (customer complaints), internal nonconformance (rework, sort, subcontractor), and quality audit nonconformance findings.

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