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.
Articles in this issue
Analytical Instrument Qualification
GMP and Phase I Clinical Trials: Streamlining the Critical Path?
Team Effort
Rated PG: Pharmaceutical Guidance Suggested
European Clinical Trial Regulations Undergo a Slow Revolution
A Practical and Cost-Effective Risk Assessment for the Validation of Commercial Laboratory Computerized Systems
Moving Biotech Products from CBER to CDER: A Work in Progress
FDA Video Interview Conducted by Jill Wechsler, Washington Bureau Chief
New Climate
2006: A Regulatory Odyssey
CDER?s Division of Post-Marketing Evaluation for Quality Assessment
Better Compliance Through Technology
Good Clinical Practice Q&A
Keeping Pace
The Growing Regulatory Burden and Revolution in Global Clinical Trials
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Inside the Laboratory: The Chromatography Laboratory at the University of Rouen
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In this edition of “Inside the Laboratory,” Pascal Cardinael and Valérie Agasse of the University of Rouen in Mont‑Saint-Aignan, France, discuss their laboratory’s work with miniaturizing gas chromatography (GC) columns and systems to improve on-site air analysis of volatile organic compounds (VOCs).
