USP 1058 Analytical Instrument Qualification - 2017

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

Who Will Benefit:

• Laboratory Managers and Staff
• Analysts
• QA Managers and Personnel
• Regulatory Affairs
• Training Departments