Analytical Instrument Qualification

In the most general sense, validation refers to a process that consists of at least four distinct components or steps: software, instruments, methods or procedures, and system suitability.

External Link - article-416287.pdf

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GMP and Phase I Clinical Trials: Streamlining the Critical Path?

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Team Effort

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Rated PG: Pharmaceutical Guidance Suggested

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European Clinical Trial Regulations Undergo a Slow Revolution

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FDA Video Interview Conducted by Jill Wechsler, Washington Bureau Chief

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New Climate

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2006: A Regulatory Odyssey

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CDER?s Division of Post-Marketing Evaluation for Quality Assessment

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