|Articles|July 1, 2006

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  • Special Issues-07-01-2006
  • Volume 0
  • Issue 0

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

Articles in this issue

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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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A Practical and Cost-Effective Risk Assessment for the Validation of Commercial Laboratory Computerized Systems

over 19 years ago

Moving Biotech Products from CBER to CDER: A Work in Progress

over 19 years ago

FDA Video Interview Conducted by Jill Wechsler, Washington Bureau Chief

over 19 years ago

New Climate

over 19 years ago

2006: A Regulatory Odyssey

over 19 years ago

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

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