USP 1058 Analytical Instrument Qualification – 2017

Congres médical/Evénement qui aura lieu le : 2017-04-19 : Spécialité: Biomedical

Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.

Areas Covered in the Session:
FDA and EU analytical instrument requirements
Most common inspection problems
Recommendations for firmware and software validation
Roles and responsibilities: QA, manufacturer, user
Qualification of existing systems

Étiquettes :

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