Compliance4All, Online Event
2017-04-19
Overview: 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
Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
|